Acute Liver FailurePhase 2NCT05689645
F573 for Injection for the Treatment of Liver Injury/Failure
A Phase 2 study testing F573 for injection and Sterilizing water for injection in people with Acute Liver Failure and Acute-On-Chronic Liver Failure, run by Beijing Continent Pharmaceutical Co, Ltd. at 10 sites in China.
Trial summary
This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial . The primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury (DILI), chronic hepatitis B (CHB), intrahepatic cholestatic liver injury, etc.). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Liver Failure, Acute-On-Chronic Liver Failure
- What is being tested?
- F573 for injection and Sterilizing water for injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 10 sitesChina
- Study dates
- 24 Mar 2023to 1 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- （1）The first stage:
- Participants who meet all of the following criteria will be enrolled in the study:
- Age ≥18 and ≤60 years old, gender is not limited;
- Patients with liver injury clinically diagnosed with hepatocyte injury or mixed liver injury or CHB patients with hepatitis B virus infection for more than 6 months (refer to the "Chronic Hepatitis B Prevention and Treatment Guidelines (2019 edition)"). Screening patients with CHB may provide etiological (HBsAg positive and/or HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results) that HBV infection has been present for more than 6 months.
- Serum ALT: 2~ 10× upper limit of normal (ULN), TBil: <5×ULN;
- DILI patients: the abnormal duration of liver biochemical indexes [ALT, AST, ALP, gamma-glutamyltranspeptides (GGT), TBil, albumin, prothrombin time] does not exceed 90 days;
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- The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last test drug administration;
- Sign informed consent and be able to comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.
- (2)The second stage:
- Subjects meeting all of the following criteria will be included in the study:
- Age ≥ 18 and ≤ 65 years old, with no gender restrictions;
- According to the "Chinese Guidelines for the Diagnosis and Treatment of Drug-Induced Liver Injury (2023 Edition)", patients diagnosed with drug-induced liver injury (DILI) or those diagnosed with intrahepatic cholestasis type liver injury. Patients with DILI and intrahepatic cholestasis type liver injury need to meet the following criteria separately;
- Patients with DILI need to simultaneously meet the following conditions: ① Serum ALT > 3 times the upper limit of normal (ULN), and TBil > 2 times the ULN (the ULN of TBil refers to 17.1 μmol/L according to international standards); ② Abnormal liver biochemical indicators (ALT, AST, ALP, TBil) persist for no more than 60 days;
- Patients with intrahepatic cholestasis type liver injury need to simultaneously meet the following conditions: ① TBil > 2 times the ULN (the ULN of TBil refers to 17.1 μmol/L); ② ALP > 1.5 times the ULN; ③ALT>1×ULN;
- The subjects (including their partners) are willing to voluntarily adopt effective contraceptive measures from the time of the initial screening until 6 months after the last administration of the investigational drug;
- They have signed the informed consent form and can comply with the requirements of the protocol; if the subjects are unable to sign the informed consent form, it must be signed by a legal guardian or a witness as required by the regulations.
- The third stage:
- Subjects who meet all of the following criteria will be enrolled in the study:
- 1. Age ≥18 and ≤70 years old, gender is not limited; 2. Patients diagnosed with chronic and acute liver failure with TBil≥5×ULN according to the "Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition)" may have hepatic encephalopathy (Grade 1-2) or ascites (grade 1-2) 4 weeks before subject screening. And 5≤AARC score ≤10 (AARC rating I-II); 3. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last trial drug administration; 4. Sign informed consent and comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.
- -
Who cannot join
- The first stage:
- Subjects meeting one of the following conditions will not be included in the trial:
- According to the investigator's judgment, the subjects were patients with cholestatic liver injury;
- Previous diagnosis of cirrhosis or liver hardness determination (LSM) at screening ≥ 12.4kPa;
- Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, and patients with malignant tumors;
- There are the following laboratory test values or abnormal test values:
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- Blood routine: platelet (PLT) <75× 109/L, hemoglobin (HGB) <90 g/L;
- Prothrombin activity <40%, prothrombin time (PT) extended >5 s;
- Left ventricular ejection fraction (LVEF) <50%;
- Allergic or intolerant to the investigational drug, or allergic;
- The subject is unable to express his main complaint, such as mental illness and severe neurosis;
- Poor compliance can not partner;
- Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;
- Participants in other clinical trials within 3 months;
- Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine within 3 days before randomization;
- The researcher considers any circumstances unsuitable for inclusion.
- The second stage:
- Subjects meeting one of the following conditions will not be included in the trial:
- The diagnosis is advanced liver cirrhosis (with complications such as ascites and hepatic encephalopathy), or liver cancer, or when liver stiffness measurement (LSM) is ≥ 18.0 kPa during screening.
- Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases are malignantTumor patients;
- There are the following laboratory test values or abnormal test values:
- Blood routine: platelet (PLT) <100×109/L, hemoglobin (HGB) <100 g/L;
- INR>1.4, or as determined by the investigator to meet the criteria for severe hepatitis;
- Left ventricular ejection fraction (LVEF) <50%;
- Allergic or intolerant to the investigational drug, or allergic;
- The subject is unable to express his main complaint, such as mental illness and severe neurosis;
- Poor compliance can not partner;
- Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;
- Participants in other clinical trials within 3 months;
- Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine and basic therapeutic drugs (polyene phosphatidylcholines and glutathione drugs) within 3 days before randomization;
- Patients who had used glucocorticoids or interferon drugs within 3 days before randomization;
- The researcher considers any circumstances unsuitable for inclusion.
- The third stage:
- Subjects meeting one of the following conditions will not be included in the trial:
- Patients who have completed liver transplantation or plan to undergo liver transplantation within 1 month;
- Severe grade 3 ascites or stubborn ascites;
- Patients with ≥ grade 3 hepatic encephalopathy;
- Patients who received artificial liver treatment within 1 week before screening;
- Patients with severe underlying diseases, such as respiratory system, digestive system, circulatory system, endocrine and other diseases and malignant tumors, and patients with severe infections that cannot be controlled by drugs;
- During the screening period or within 1 month before screening, the results of gastroscopy or imaging (abdominal B-ultrasound, CT or MRI) examination suggest severe varicose veins with bleeding risk;
- Patients with acute kidney injury (AKI), defined as meeting one of the following conditions:
- Serum creatinine (Scr) increased ≥26.5 μmol/L (0.3 mg/dL, 1 mg/dL=88.4 μmol/L) within 48 h;
- The Scr increase exceeds 1.5 times or more of the base value within 7 days;
- Decreased urine volume (<0.5 mL/kg/h) for more than 6 hours;
- Allergic or intolerant to the investigational drug, or allergic;
- The subject is unable to express his main complaint, such as mental illness and severe neurosis;
- Poor compliance can not partner; 11 Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;
- 12. Participants in other clinical trials within 3 months; 13. The researcher considers any circumstances unsuitable for inclusion.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
junqi niu, Dr contact
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Beijing You 'an Hospital, Capital Medical University
Beijing, Beijing Municipality
Yu Cheng
- Recruiting
The Affiliated Hospital of Binzhou Medical University
Binzhou, Shandong
Chengxia liu
- Recruiting
First Hospital of Jilin University
Changchun, Jilin
junqi niu, Dr
- Recruiting
Heze Municipal Hospital
Heze, Shandong
fangqi ge
- Recruiting
Hunan Medical College General Hospital (formerly Huaihua City First People's Hospital)
Huaihua, Hunan
yongzhong Li
- Recruiting
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
mingming deng
- Recruiting
Pingxiang Second People's Hospital
Pingxiang, Jiangxi P
shuqiang ou
- Recruiting
Qingyuan People's Hospital (Sixth Affiliated Hospital of Guangzhou Medical University)
Qingyuan, Guangdong
bei zhong
- Recruiting
Shiyan City Taihe Hospital
Shiyan, Hubei
zhongji meng
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Jia / Yan Yao / Wang
About this study
Official title: F573 for Injection for the Treatment of Liver Injury/Failure : Randomized, Double-blind, Placebo-controlled Phase Ⅱa Clinical Trial
This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial .
The primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury (DILI), chronic hepatitis B (CHB), intrahepatic cholestatic liver injury, etc.).
Read the detailed description
In a randomized, double-blind, placebo-controlled design, the study was divided into two phases according to the subjects' risk of liver failure due to liver injury.
The first stage: Twenty-five patients with liver injury (DILI patients and other types of patients with the same degree of liver injury) were enrolled. The trial was first conducted in 16 participants who were treated with the experimental drug or placebo at a 1:1:1:1 ratio of 0.5, 1.0, and 2.0 mg/kg. Then, 9 patients with CHB were treated with the experimental drug, and the dose was determined to be 2.0 mg/kg according to the efficacy and safety test results of the 16 patients enrolled first.After subject consent is obtained, pharmacokinetic blood samples will be collected from 9 CHB patients subsequently enrolled in Phase I.
The second stage:A total of 24 patients with liver injury (DILI patients and intrahepatic cholestasis type liver injury) were enrolled, and qualified subjects were treated with the experimental drug or placebo in a ratio of 3:1, once a day for 14 days. The dosage was determined to be 0.5 mg/kg and 2.0 mg/kg based on the results of phase I efficacy and safety trials. First, a trial was conducted in the 0.5 mg/kg dose group, and 12 subjects were enrolled and treated with the test drug or placebo at a ratio of 3:1, once a day for 14 days. After the 0.5 mg/kg dose group was completed, the experiment of 2.0 mg/kg dose group was carried out. 12 subjects were also enrolled and received the test drug or placebo in a ratio of 3:1, once a day for 14 days.
The Third stage:
The study was randomized, double-blind, placebo-controlled. The study was divided into a screening period (14 days), treatment period (28 days), and follow-up period (90 days).
Eligible subjects were given the experimental drug or placebo in a ratio of 3:1, once a day for 28 days, and the dose was determined according to the efficacy and safety results of phase I and Phase II trials. Subjects also received the drug acetyl cysteine injection (NAC). After discontinuation, participants were followed for 90 days for safety. During the study, subjects were visited at planned sites for clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiography, abdominal B-ultrasonography, cardiac color ultrasonography, biomarker testing, MELD score, AARC score, survival status assessment, monitoring of AE, and recording of subjects' concomitant/concomitant medications.
- Being tested
- F573 for injection, Sterilizing water for injection
- Keywords
- F573 for injection Liver Injury/Failure
- Medical subject headings
- Liver Failure, Acute, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F573 for injectionDrug
The first stage:the first 16 patients with liver injury were given doses of 0.5, 1.0 and 2.0 mg/kg, and the subsequent 9 patients with CHB were given doses of 2.0 mg/kg, with an administration volume of 2 mL and intramuscular injection (IM) according to the efficacy and safety test results of the first 16 patients. The dose was given once a day for 7 days and calculated according to the weight of the last visit.
The second stage:According to the results of Phase I efficacy and safety trials, the dosage was determined to be 0.5 mg/kg and 2.0 mg/kg, the dosage volume was 2 mL, intramuscular injection (IM), once a day for 14 days, and the dosage was calculated according to the weight of the latest visit.
The third stage:The dosage was determined according to the results of the first and second phase efficacy and safety trials. The dosage volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days, and the dosage was calculated according to the weight of the latest .
Sterilizing water for injectionDrug
The composition of this product is water for injection, and the dosage volume is 2mL for intramuscular injection.
Medication course: The first stages were administered once a day for 7 days and second stages were administered once a day for 14 days. The third stage was administered once a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| F573 for injection groups | Experimental | The first stage:the first 16 patients with liver injury were given doses of 0.5, 1.0 and 2.0 mg/kg, and the subsequent 9 patients with CHB were given doses of 2.0 mg/kg, with an administration volume of 2 mL and intramuscular injection (IM) according to the efficacy and safety test results of the first 16 patients. The dose was given once a day for 7 days and calculated according to the weight of the last visit.
The second stage:According to the results of Phase I efficacy and safety trials, the dosage was determined to be 0.5 mg/kg and 2.0 mg/kg, the dosage volume was 2 mL, intramuscular injection (IM), once a day for 14 days, and the dosage was calculated according to the weight of the latest visit.
The third stage:The dosage was determined according to the results of the first and second phase efficacy and safety trials. The dosage volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days, and the dosage was calculated according to the weight of the latest Receives: Drug: F573 for injection |
| Placebo Comparator | Placebo comparator | 1. The first stage: The dosage was 2 mL by intramuscular injection (IM) once a day for 7 days.
Basic treatment: enteric-coated diammonium glycyrrhizinate capsules were administered at a dose of 150 mg 3 times a day.
2. The second stage: The dosage was 2 mL by intramuscular injection (IM) once a day for 14 days.
Basic treatment: Polyene phosphatidylcholines and glutathione drugs (no restricted dosage forms) are accepted as basic treatment.
3. The third stage: the Screen eligible subjects were treated with Sterilizing water for injection. The dose volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days. Basic treatment: receive acetylcysteine injection at a dose of 8 g / d once a day. Receives: Drug: Sterilizing water for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE), serious adverse events (SAE)
to record Adverse events and serious adverse events in the trial
Measured: 7 days of administration in the first stage and 14 days of administration in the second stage
Adverse events (AE), serious adverse events (SAE)
to record Adverse events and serious adverse events in the trial
Measured: followed up for 28 days in the first stage and followed up for 14 days in the second stage
clinical laboratory tests ：blood routine
blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.
Measured: 7 days of administration in the first stage and 14 days of administration in the second stage
clinical laboratory tests ：blood routine
blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.
Measured: followed up for 28 days in the first stage and followed up for 14 days in the second stage
clinical laboratory tests ：blood biochemistry
blood biochemistry report contains the following values: DBIL,TBIL,Urea，BUN,Cr，AST，ALT，GGT, TP, ALB, GLU,TG, TC, K,Na,CI, UA,LDH, ALP, PAB, RBP, AFP.
Measured: 7 days of administration in the first stage and 14 days of administration in the second stage
clinical laboratory tests ：blood biochemistry
blood biochemistry report contains the following values: DBIL,TBIL,Urea，BUN,Cr，AST，ALT，GGT, TP, ALB, GLU,TG, TC, K,Na,CI, UA,LDH, ALP, PAB, RBP, AFP.
Measured: followed up for 28 days in the first stage and followed up for 14 days in the second stage
clinical laboratory tests : urine routine
urine routine report contains the following values: GLU,PRO,RBC,WBC.
Measured: 7 days of administration in the first stage and 14 days of administration in the second stage
clinical laboratory tests : urine routine
urine routine report contains the following values: GLU,PRO,RBC,WBC.
Measured: followed up for 28 days in the first stage and followed up for 14 days in the second stage
clinical laboratory tests ：blood coagulation function
blood coagulation function report contains the following values: TT, APTT, PT, INR.
Measured: 7 days of administration in the first stage and 14 days of administration in the second stage
clinical laboratory tests ：blood coagulation function
blood coagulation function report contains the following values: TT, APTT, PT, INR.
Measured: followed up for 28 days in the first stage and followed up for 14 days in the second stage
12-lead electrocardiogram (ECG)
12-lead electrocardiogram (ECG) report contains the following values: HR, BP,DP,PR intervals,QRS intervals,QT intervals,QTc intervals.
Measured: 7 days of administration in the first stage and 14 days of administration in the second stage
12-lead electrocardiogram (ECG)
12-lead electrocardiogram (ECG) report contains the following values: HR, BP,DP,PR intervals,QRS intervals,QT intervals,QTc intervals.
Measured: followed up for 28 days in the first stage and followed up for 14 days in the second stage
All-cause mortality
All-cause mortality within 28 days after completion of dosing.
Measured: 28 days after completion of dosing in the third stage
All-cause mortality
All-cause mortality within 90 days after completion of dosing.
Measured: 90 days after completion of dosing in the third stage
Secondary outcomes (91)
Basin alanine aminotransferase (ALT)
ALT values reflect hepatocyte injury
Measured: after 7 days of administration in the first and second stages
Basin alanine aminotransferase (ALT)
ALT values reflect hepatocyte injury
Measured: after 14 days of administration in the second stages
Basin alanine aminotransferase (ALT)
ALT values reflect hepatocyte injury
Measured: followed up for 28 days in the first stage and followed up for 14 days in the second stage
peak concentration (Cmax)
Pharmacokinetic parameters: peak concentration (Cmax).
Measured: 12 hours after administration in the first and second stages
Peak-reaching time (Tmax)
Pharmacokinetic parameters: Peak-reaching time (Tmax)
Measured: 12 hours after administration in the first and second stages
half-life period (T1/2)
Pharmacokinetic parameters: half-life period (T1/2)
Measured: 12 hours after administration in the first and second stages
Blood concentration-area (AUC)
Blood concentration-area (AUC) under the time curve from zero to t0-t), Area under the blood concentration-time curve from 0 to infinite time (AUC0-∞).
Measured: 12 hours after administration in the first and second stages
Clearance rate (CL / F)
Pharmacokinetic parameters: Clearance rate (CL / F).
Measured: 12 hours after administration in the first and second stages
apparent distribution volume (Vz / F)
Pharmacokinetic parameters: apparent distribution volume (Vz / F).
Measured: 12 hours after administration in the first and second stages
average retention time (MRT)
Pharmacokinetic parameters: average retention time (MRT)
Measured: 12 hours after administration in the first and second stages
Aspartate aminotransferase (AST)
Changes in biomarkers from baseline include ALT, aspartate aminotransferase (AST).
Measured: after 7 days of administration in the first and 14 days of administration in second stages
total bilirubin (TBil)
Changes in biomarkers from baseline include total bilirubin (TBil).
Measured: after 7 days of administration in the first and 14 days of administration in second stages
prothrombin activity (PTA)
Changes in biomarkers from baseline include prothrombin activity (PTA).
Measured: after 7 days of administration in the first and 14 days of administration in second stages
international normalized ratio (INR)
Changes in biomarkers from baseline include international normalized ratio (INR).
Measured: after 7 days of administration in the first and 14 days of administration in second stages
alkaline phosphatase (ALP)
Changes in biomarkers from baseline include alkaline phosphatase (ALP)
Measured: after 7 days of administration in the first and 14 days of administration in second stages
Alpha-fetoprotein(AFP)
Changes in biomarkers from baseline include Alpha-fetoprotein (AFP).
Measured: after 7 days of administration in the first and 14 days of administration in second stages
CK-18 M30
Changes in biomarkers from baseline include c aspase digested keratin 18M 30 (CK-18 M30)
Measured: after 7 days of administration in the first and 14 days of administration in second stages
caspase 3
Changes in biomarkers from baseline include caspase 3
Measured: after 7 days of administration in the first and 14 days of administration in second stages
caspase 1
Changes in biomarkers from baseline include caspase 1.
Measured: after 7 days of administration in the first and 14 days of administration in second stages
hepatocyte growth factor (HGF)
Changes in biomarkers from baseline include hepatocyte growth factor (HGF)
Measured: after 7 days of administration in the first and 14 days of administration in second stages
the end-stage liver disease model (MELD) score
Changes of the end-stage liver disease model (MELD) score. Higher scores indicate more severe disease.
Measured: 7 days of administration in the third stage secondary outcome
the end-stage liver disease model (MELD) score
Changes of the end-stage liver disease model (MELD) score. Higher scores indicate more severe disease.
Measured: 14 days of administration in the third stage secondary outcome
the end-stage liver disease model (MELD) score
Changes of the end-stage liver disease model (MELD) score. Higher scores indicate more severe disease.
Measured: 28 days of administration in the third stage secondary outcome
the end-stage liver disease model (MELD) score
Changes of the end-stage liver disease model (MELD) score. Higher scores indicate more severe disease.
Measured: 28 days of follow-up in the third stage secondary outcome
the end-stage liver disease model (MELD) score
Changes of the end-stage liver disease model (MELD) score. Higher scores indicate more severe disease.
Measured: 90 days of follow-up in the third stage secondary outcome
ACLF Research Consortium (AARC) score
Changes of ACLF Research Consortium (AARC) score. Higher scores indicate more severe disease.
Measured: 7 days of administration in the third stage
ACLF Research Consortium (AARC) score
Changes of ACLF Research Consortium (AARC) score. Higher scores indicate more severe disease.
Measured: 14 days of administration in the third stage
ACLF Research Consortium (AARC) score
Changes of ACLF Research Consortium (AARC) score. Higher scores indicate more severe disease.
Measured: 28 days of administration in the third stage
ACLF Research Consortium (AARC) score
Changes of ACLF Research Consortium (AARC) score. Higher scores indicate more severe disease.
Measured: 28 days of follow-up in the third stage
ACLF Research Consortium (AARC) score
Changes of ACLF Research Consortium (AARC) score. Higher scores indicate more severe disease.
Measured: 90 days of follow-up in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Changes in biomarkers compared to baseline include ALT and AST.
Measured: 7 days of administration in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Changes in biomarkers compared to baseline include ALT and AST.
Measured: 14 days of administration in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Changes in biomarkers compared to baseline include ALT and AST.
Measured: 28 days of administration in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Changes in biomarkers compared to baseline include ALT and AST.
Measured: 28 days of follow-up in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Changes in biomarkers compared to baseline include ALT and AST.
Measured: 90 days of follow-up in the third stage
total bilirubin (TBil)
Changes in biomarkers compared to baseline include TBil.
Measured: 7 days of administration in the third stage
total bilirubin (TBil)
Changes in biomarkers compared to baseline include TBil.
Measured: 14 days of administration in the third stage
total bilirubin (TBil)
Changes in biomarkers compared to baseline include TBil.
Measured: 28 days of administration in the third stage
total bilirubin (TBil)
Changes in biomarkers compared to baseline include TBil.
Measured: 28 days of follow-up in the third stage
total bilirubin (TBil)
Changes in biomarkers compared to baseline include TBil.
Measured: 90 days of follow-up in the third stage
prothrombin activity (PTA)
Changes in biomarkers compared to baseline include PTA.
Measured: 7 days of administration in the third stage
prothrombin activity (PTA)
Changes in biomarkers compared to baseline include PTA.
Measured: 14 days of administration in the third stage
prothrombin activity (PTA)
Changes in biomarkers compared to baseline include PTA.
Measured: 28 days of administration in the third stage
prothrombin activity (PTA)
Changes in biomarkers compared to baseline include PTA.
Measured: 28 days of follow-up in the third stage
prothrombin activity (PTA)
Changes in biomarkers compared to baseline include PTA.
Measured: 90 days of follow-up in the third stage
international normalized ratio (INR)
Changes in biomarkers compared to baseline include international normalized ratio (INR).
Measured: 7 days of administration in the third stage
international normalized ratio (INR)
Changes in biomarkers compared to baseline include international normalized ratio (INR).
Measured: 14 days of administration in the third stage
international normalized ratio (INR)
Changes in biomarkers compared to baseline include international normalized ratio (INR).
Measured: 28 days of administration in the third stage
international normalized ratio (INR)
Changes in biomarkers compared to baseline include international normalized ratio (INR).
Measured: 90 days of follow-up in the third stage
alkaline phosphatase (ALP)
Changes in biomarkers compared to baseline include alkaline phosphatase (ALP).
Measured: 7 days of administration in the third stage
alkaline phosphatase (ALP)
Changes in biomarkers compared to baseline include alkaline phosphatase (ALP).
Measured: 14 days of administration in the third stage
alkaline phosphatase (ALP)
Changes in biomarkers compared to baseline include alkaline phosphatase (ALP).
Measured: 28 days of administration in the third stage
alkaline phosphatase (ALP)
Changes in biomarkers compared to baseline include alkaline phosphatase (ALP).
Measured: 28 days of follow-up in the third stage
alkaline phosphatase (ALP)
Changes in biomarkers compared to baseline include alkaline phosphatase (ALP).
Measured: 90 days of follow-up in the third stage
Alpha-fetoprotein(AFP)
Changes in biomarkers compared to baseline include Alpha-fetoprotein(AFP) .
Measured: 7 days of administration in the third stage
Alpha-fetoprotein(AFP)
Changes in biomarkers compared to baseline include Alpha-fetoprotein(AFP) .
Measured: 14 days of administration in the third stage
Alpha-fetoprotein(AFP)
Changes in biomarkers compared to baseline include Alpha-fetoprotein(AFP) .
Measured: 28 days of administration in the third stage
Alpha-fetoprotein(AFP)
Changes in biomarkers compared to baseline include Alpha-fetoprotein(AFP) .
Measured: 28 days of follow-up in the third stage
Alpha-fetoprotein(AFP)
Changes in biomarkers compared to baseline include Alpha-fetoprotein(AFP) .
Measured: 90 days of follow-up in the third stage
CK-18 M30
Changes in biomarkers from baseline include c aspase digested keratin 18M 30 (CK-18 M30)
Measured: 7 days of administration in the third stage
CK-18 M30
Changes in biomarkers from baseline include c aspase digested keratin 18M 30 (CK-18 M30)
Measured: 14 days of administration in the third stage
CK-18 M30
Changes in biomarkers from baseline include c aspase digested keratin 18M 30 (CK-18 M30)
Measured: 28 days of administration in the third stage
CK-18 M30
Changes in biomarkers from baseline include c aspase digested keratin 18M 30 (CK-18 M30)
Measured: 28 days of follow-up in the third stage
CK-18 M30
Changes in biomarkers from baseline include c aspase digested keratin 18M 30 (CK-18 M30)
Measured: 90 days of follow-up in the third stage
caspase 3
Changes in biomarkers from baseline include caspase 3
Measured: 7 days of administration in the third stage
caspase 3
Changes in biomarkers from baseline include caspase 3
Measured: 14 of administration in the third stage
caspase 3 / 7
Changes in biomarkers from baseline include caspase 3
Measured: 28 days of administration in the third stage
caspase 3
Changes in biomarkers from baseline include caspase 3
Measured: 28 days of follow-up in the third stage
caspase 3
Changes in biomarkers from baseline include caspase 3
Measured: 90 days of follow-up in the third stage
caspase 1
Changes in biomarkers from baseline include caspase 1.
Measured: 7 days of administration in the third stage
caspase 1
Changes in biomarkers from baseline include caspase 1.
Measured: 14 days of administration in the third stage
caspase 1
Changes in biomarkers from baseline include caspase 1.
Measured: 28 days of administration in the third stage
caspase 1
Changes in biomarkers from baseline include caspase 1.
Measured: 28 days of follow-up in the third stage
caspase 1
Changes in biomarkers from baseline include caspase 1.
Measured: 90 days of follow-up in the third stage
hepatocyte growth factor (HGF)
Changes in biomarkers from baseline include hepatocyte growth factor (HGF)
Measured: 7 days of administration in the third stage
hepatocyte growth factor (HGF)
Changes in biomarkers from baseline include hepatocyte growth factor (HGF)
Measured: 14 days of administration in the third stage
hepatocyte growth factor (HGF)
Changes in biomarkers from baseline include hepatocyte growth factor (HGF)
Measured: 28 days of administration in the third stage
hepatocyte growth factor (HGF)
Changes in biomarkers from baseline include hepatocyte growth factor (HGF)
Measured: 28 days of follow-up in the third stage
hepatocyte growth factor (HGF)
Changes in biomarkers from baseline include hepatocyte growth factor (HGF)
Measured: 90 days of follow-up in the third stage
Adverse events (AE), serious adverse events (SAE)
Adverse events (AE), serious adverse events (SAE) in the third stage at 28 days
Measured: 28 days of follow-up in the third stage.
Adverse events (AE), serious adverse events (SAE)
Adverse events (AE), serious adverse events (SAE) in the third stage at 28 days
Measured: 90 days of follow-up in the third stage.
clinical laboratory tests ：blood routine
blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.
Measured: 28 days of follow-up ihe third stage.
clinical laboratory tests ：blood routine
blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.
Measured: 90 days of follow-up ihe third stage.
clinical laboratory tests ：blood biochemistry
blood biochemistry report contains the following values: DBIL,TBIL,Urea，BUN,Cr，AST，ALT，GGT, TP, ALB, GLU,TG, TC, K,Na,CI, UA,LDH, ALP, PAB, RBP, AFP.
Measured: 28 of follow-up ihe third stage.
clinical laboratory tests ：blood biochemistry
blood biochemistry report contains the following values: DBIL,TBIL,Urea，BUN,Cr，AST，ALT，GGT, TP, ALB, GLU,TG, TC, K,Na,CI, UA,LDH, ALP, PAB, RBP, AFP.
Measured: 90 days of follow-up ihe third stage.
clinical laboratory tests ：urine routine
urine routine report contains the following values: GLU,PRO,RBC,WBC.
Measured: 28 days of follow-up ihe third stage.
clinical laboratory tests ：urine routine
urine routine report contains the following values: GLU,PRO,RBC,WBC.
Measured: 90 days of follow-up ihe third stage.
clinical laboratory tests ：blood coagulation function
blood coagulation function report contains the following values: TT, APTT, PT, INR.
Measured: 28 days of follow-up ihe third stage.
clinical laboratory tests ：blood coagulation function
blood coagulation function report contains the following values: TT, APTT, PT, INR.
Measured: 90 days of follow-up ihe third stage.
12-lead electrocardiogram (ECG)
12-lead electrocardiogram (ECG) report contains the following values: HR, BP,DP,PR intervals,QRS intervals,QT intervals,QTc intervals.
Measured: 28 days of follow-up ihe third stage.
12-lead electrocardiogram (ECG)
12-lead electrocardiogram (ECG) report contains the following values: HR, BP,DP,PR intervals,QRS intervals,QT intervals,QTc intervals.
Measured: 90 days of follow-up ihe third stage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start24 Mar 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689645
- Sponsor's protocol ID
- KDN-F573-202202
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F573 for Injection for the Treatment of Liver Injury/Failure : Randomized, Double-blind, Placebo-controlled Phase Ⅱa Clinical Trial
- ClinicalTrials.gov ID
- NCT05689645
- Acronym / sponsor ID
- KDN-F573-202202
- Keywords
- F573 for injection Liver Injury/Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial .
The primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury (DILI), chronic hepatitis B (CHB), intrahepatic cholestatic liver injury, etc.).
Detailed description
In a randomized, double-blind, placebo-controlled design, the study was divided into two phases according to the subjects' risk of liver failure due to liver injury.
The first stage: Twenty-five patients with liver injury (DILI patients and other types of patients with the same degree of liver injury) were enrolled. The trial was first conducted in 16 participants who were treated with the experimental drug or placebo at a 1:1:1:1 ratio of 0.5, 1.0, and 2.0 mg/kg. Then, 9 patients with CHB were treated with the experimental drug, and the dose was determined to be 2.0 mg/kg according to the efficacy and safety test results of the 16 patients enrolled first.After subject consent is obtained, pharmacokinetic blood samples will be collected from 9 CHB patients subsequently enrolled in Phase I.
The second stage:A total of 24 patients with liver injury (DILI patients and intrahepatic cholestasis type liver injury) were enrolled, and qualified subjects were treated with the experimental drug or placebo in a ratio of 3:1, once a day for 14 days. The dosage was determined to be 0.5 mg/kg and 2.0 mg/kg based on the results of phase I efficacy and safety trials. First, a trial was conducted in the 0.5 mg/kg dose group, and 12 subjects were enrolled and treated with the test drug or placebo at a ratio of 3:1, once a day for 14 days. After the 0.5 mg/kg dose group was completed, the experiment of 2.0 mg/kg dose group was carried out. 12 subjects were also enrolled and received the test drug or placebo in a ratio of 3:1, once a day for 14 days.
The Third stage:
The study was randomized, double-blind, placebo-controlled. The study was divided into a screening period (14 days), treatment period (28 days), and follow-up period (90 days).
Eligible subjects were given the experimental drug or placebo in a ratio of 3:1, once a day for 28 days, and the dose was determined according to the efficacy and safety results of phase I and Phase II trials. Subjects also received the drug acetyl cysteine injection (NAC). After discontinuation, participants were followed for 90 days for safety. During the study, subjects were visited at planned sites for clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiography, abdominal B-ultrasonography, cardiac color ultrasonography, biomarker testing, MELD score, AARC score, survival status assessment, monitoring of AE, and recording of subjects' concomitant/concomitant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F573 for injection groups | Experimental | Drug: F573 for injectionThe first stage:the first 16 patients with liver injury were given doses of 0.5, 1.0 and 2.0 mg/kg, and the subsequent 9 patients with CHB were given doses of 2.0 mg/kg, with an administration volume of 2 mL and intramuscular injection (IM) according to the efficacy and safety test results of the first 16 patients. The dose was given once a day for 7 days and calculated according to the weight of the last visit. The second stage:According to the results of Phase I efficacy and safety trials, the dosage was determined to be 0.5 mg/kg and 2.0 mg/kg, the dosage volume was 2 mL, intramuscular injection (IM), once a day for 14 days, and the dosage was calculated according to the weight of the latest visit. The third stage:The dosage was determined according to the results of the first and second phase efficacy and safety trials. The dosage volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days, and the dosage was calculated according to the weight of the latest |
| Placebo Comparator | Placebo comparator | Drug: Sterilizing water for injection1. The first stage: The dosage was 2 mL by intramuscular injection (IM) once a day for 7 days. Basic treatment: enteric-coated diammonium glycyrrhizinate capsules were administered at a dose of 150 mg 3 times a day. 2. The second stage: The dosage was 2 mL by intramuscular injection (IM) once a day for 14 days. Basic treatment: Polyene phosphatidylcholines and glutathione drugs (no restricted dosage forms) are accepted as basic treatment. 3. The third stage: the Screen eligible subjects were treated with Sterilizing water for injection. The dose volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days. Basic treatment: receive acetylcysteine injection at a dose of 8 g / d once a day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Age ≥18 and ≤60 years old, gender is not limited;
- Patients with liver injury clinically diagnosed with hepatocyte injury or mixed liver injury or CHB patients with hepatitis B virus infection for more than 6 months (refer to the "Chronic Hepatitis B Prevention and Treatment Guidelines (2019 edition)"). Screening patients with CHB may provide etiological (HBsAg positive and/or HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results) that HBV infection has been present for more than 6 months.
- Serum ALT: 2~ 10× upper limit of normal (ULN), TBil: <5×ULN;
- DILI patients: the abnormal duration of liver biochemical indexes [ALT, AST, ALP, gamma-glutamyltranspeptides (GGT), TBil, albumin, prothrombin time] does not exceed 90 days;
- The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last test drug administration;
Key exclusion criteria (48 listed)
- According to the investigator's judgment, the subjects were patients with cholestatic liver injury;
- Previous diagnosis of cirrhosis or liver hardness determination (LSM) at screening ≥ 12.4kPa;
- Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, and patients with malignant tumors;
- There are the following laboratory test values or abnormal test values:
- Allergic or intolerant to the investigational drug, or allergic;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F573 for injectionThe first stage:the first 16 patients with liver injury were given doses of 0.5, 1.0 and 2.0 mg/kg, and the subsequent 9 patients with CHB were given doses of 2.0 mg/kg, with an administration volume of 2 mL and intramuscular injection (IM) according to the efficacy and safety test results of the first 16 patients. The dose was given once a day for 7 days and calculated according to the weight of the last visit. The second stage:According to the results of Phase I efficacy and safety trials, the dosage was determined to be 0.5 mg/kg and 2.0 mg/kg, the dosage volume was 2 mL, intramuscular injection (IM), once a day for 14 days, and the dosage was calculated according to the weight of the latest visit. The third stage:The dosage was determined according to the results of the first and second phase efficacy and safety trials. The dosage volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days, and the dosage was calculated according to the weight of the latest . | Drug | F573 for injection groups |
| Sterilizing water for injectionThe composition of this product is water for injection, and the dosage volume is 2mL for intramuscular injection. Medication course: The first stages were administered once a day for 7 days and second stages were administered once a day for 14 days. The third stage was administered once a day for 28 days. | Drug | Placebo Comparator |
Primary outcome
Adverse events (AE), serious adverse events (SAE)
Time frame: 7 days of administration in the first stage and 14 days of administration in the second stage
to record Adverse events and serious adverse events in the trial
Adverse events (AE), serious adverse events (SAE)
Time frame: followed up for 28 days in the first stage and followed up for 14 days in the second stage
to record Adverse events and serious adverse events in the trial
clinical laboratory tests ：blood routine
Time frame: 7 days of administration in the first stage and 14 days of administration in the second stage
blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.
clinical laboratory tests ：blood routine
Time frame: followed up for 28 days in the first stage and followed up for 14 days in the second stage
blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.
clinical laboratory tests ：blood biochemistry
Time frame: 7 days of administration in the first stage and 14 days of administration in the second stage
blood biochemistry report contains the following values: DBIL,TBIL,Urea，BUN,Cr，AST，ALT，GGT, TP, ALB, GLU,TG, TC, K,Na,CI, UA,LDH, ALP, PAB, RBP, AFP.
clinical laboratory tests ：blood biochemistry
Time frame: followed up for 28 days in the first stage and followed up for 14 days in the second stage
blood biochemistry report contains the following values: DBIL,TBIL,Urea，BUN,Cr，AST，ALT，GGT, TP, ALB, GLU,TG, TC, K,Na,CI, UA,LDH, ALP, PAB, RBP, AFP.
clinical laboratory tests : urine routine
Time frame: 7 days of administration in the first stage and 14 days of administration in the second stage
urine routine report contains the following values: GLU,PRO,RBC,WBC.
clinical laboratory tests : urine routine
Time frame: followed up for 28 days in the first stage and followed up for 14 days in the second stage
urine routine report contains the following values: GLU,PRO,RBC,WBC.
clinical laboratory tests ：blood coagulation function
Time frame: 7 days of administration in the first stage and 14 days of administration in the second stage
blood coagulation function report contains the following values: TT, APTT, PT, INR.
clinical laboratory tests ：blood coagulation function
Time frame: followed up for 28 days in the first stage and followed up for 14 days in the second stage
blood coagulation function report contains the following values: TT, APTT, PT, INR.
12-lead electrocardiogram (ECG)
Time frame: 7 days of administration in the first stage and 14 days of administration in the second stage
12-lead electrocardiogram (ECG) report contains the following values: HR, BP,DP,PR intervals,QRS intervals,QT intervals,QTc intervals.
12-lead electrocardiogram (ECG)
Time frame: followed up for 28 days in the first stage and followed up for 14 days in the second stage
12-lead electrocardiogram (ECG) report contains the following values: HR, BP,DP,PR intervals,QRS intervals,QT intervals,QTc intervals.
All-cause mortality
Time frame: 28 days after completion of dosing in the third stage
All-cause mortality within 28 days after completion of dosing.
All-cause mortality
Time frame: 90 days after completion of dosing in the third stage
All-cause mortality within 90 days after completion of dosing.
91 secondary outcomes
Basin alanine aminotransferase (ALT)
Time frame: after 7 days of administration in the first and second stages
Basin alanine aminotransferase (ALT)
Time frame: after 14 days of administration in the second stages
Basin alanine aminotransferase (ALT)
Time frame: followed up for 28 days in the first stage and followed up for 14 days in the second stage
peak concentration (Cmax)
Time frame: 12 hours after administration in the first and second stages
Peak-reaching time (Tmax)
Time frame: 12 hours after administration in the first and second stages
half-life period (T1/2)
Time frame: 12 hours after administration in the first and second stages
Blood concentration-area (AUC)
Time frame: 12 hours after administration in the first and second stages
Clearance rate (CL / F)
Time frame: 12 hours after administration in the first and second stages
apparent distribution volume (Vz / F)
Time frame: 12 hours after administration in the first and second stages
average retention time (MRT)
Time frame: 12 hours after administration in the first and second stages
Aspartate aminotransferase (AST)
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
total bilirubin (TBil)
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
prothrombin activity (PTA)
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
international normalized ratio (INR)
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
alkaline phosphatase (ALP)
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
Alpha-fetoprotein(AFP)
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
CK-18 M30
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
caspase 3
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
caspase 1
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
hepatocyte growth factor (HGF)
Time frame: after 7 days of administration in the first and 14 days of administration in second stages
the end-stage liver disease model (MELD) score
Time frame: 7 days of administration in the third stage secondary outcome
the end-stage liver disease model (MELD) score
Time frame: 14 days of administration in the third stage secondary outcome
the end-stage liver disease model (MELD) score
Time frame: 28 days of administration in the third stage secondary outcome
the end-stage liver disease model (MELD) score
Time frame: 28 days of follow-up in the third stage secondary outcome
the end-stage liver disease model (MELD) score
Time frame: 90 days of follow-up in the third stage secondary outcome
ACLF Research Consortium (AARC) score
Time frame: 7 days of administration in the third stage
ACLF Research Consortium (AARC) score
Time frame: 14 days of administration in the third stage
ACLF Research Consortium (AARC) score
Time frame: 28 days of administration in the third stage
ACLF Research Consortium (AARC) score
Time frame: 28 days of follow-up in the third stage
ACLF Research Consortium (AARC) score
Time frame: 90 days of follow-up in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Time frame: 7 days of administration in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Time frame: 14 days of administration in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Time frame: 28 days of administration in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Time frame: 28 days of follow-up in the third stage
Basin alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Time frame: 90 days of follow-up in the third stage
total bilirubin (TBil)
Time frame: 7 days of administration in the third stage
total bilirubin (TBil)
Time frame: 14 days of administration in the third stage
total bilirubin (TBil)
Time frame: 28 days of administration in the third stage
total bilirubin (TBil)
Time frame: 28 days of follow-up in the third stage
total bilirubin (TBil)
Time frame: 90 days of follow-up in the third stage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
junqi niu, Dr contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F573 for injection and Sterilizing water for injection in people with Acute Liver Failure and Acute-On-Chronic Liver Failure, run by Beijing Continent Pharmaceutical Co, Ltd. at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ling zhang, Dr (13501209210 ext. +86, zhangling@bjcontinent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE), serious adverse events (SAE) (time frame: 7 days of administration in the first stage and 14 days of administration in the second stage). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.