Liver FibrosisPhase 3NCT07412236
A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.
A Phase 3 study testing Hydronidone (270mg) in people with Liver Fibrosis and Liver Fibrosis in Chronic Hepatitis B, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Fibrosis, Liver Fibrosis in Chronic Hepatitis B
- What is being tested?
- Hydronidone (270mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,208 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2026to 30 Dec 2028
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years (inclusive of 18 and 65 years old at the time of signing the informed consent form), male or female;
- Documented history of chronic hepatitis B and/or positive for hepatitis B surface antigen (HBsAg) for ≥6 months;
- Treatment-naïve or treatment-experienced patients with chronic hepatitis B, defined as follows:
- Treatment-naïve patients must meet all of the following criteria:
- No prior systemic antiviral therapy (e.g., interferon and/or nucleos(t)ide analogues) before randomization;
- Positive for HBV DNA;
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- Liver stiffness measurement (LSM) by transient elastography ≥12.4 kPa for treatment-naïve patients with ALT >2 × ULN; or LSM ≥10.6 kPa for treatment-naïve patients with ALT ≤2 × ULN. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.
- Treatment-experienced patients must meet all of the following criteria:
- A history of ≥6 months of continuous nucleos(t)ide analogue therapy for hepatitis B up to randomization, currently receiving monotherapy with a nucleos(t)ide analogue [e.g., Tenofovir Alafenamide Fumarate (TAF), Tenofovir Disoproxil Fumarate (TDF), or Entecavir (ETV)];
- HBV DNA positive or negative is acceptable;
- Liver stiffness measurement (LSM) by transient elastography >9.0 kPa. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.
- ALT <8 × ULN;
- No use within 3 months prior to randomization of the following Chinese patent medicines that may have antifibrotic effects: Fuzhenghuayu Capsule (Tablet), Anluohuaxian Pill, Compound Biejia Ruangan Tablet, etc.;
- Subjects (or their sexual partners) have no pregnancy plan during the trial and for 6 months after trial completion, voluntarily agree to use effective physical contraceptive methods, and have no plan to donate sperm or eggs;
- Subjects have fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to participation, voluntarily agree to take part in this clinical trial, are able to communicate well with the investigators, agree to comply with all study requirements, and have provided written informed consent.
Who cannot join
- Total bilirubin (TBil) >3 × ULN, or 3 × ULN < ALT <8 × ULN with TBil >2 × ULN;
- Platelet count (PLT) ≤50 × 10⁹/L;
- Prothrombin activity (PTA) <50% or International Normalized Ratio (INR) >1.5;
- Imaging findings suggestive of a space-occupying lesion in the liver indicative of tumor, or alpha-fetoprotein (AFP) >100 μg/L even in the absence of specific signs of hepatocellular carcinoma;
- Patients with decompensated liver cirrhosis (complications including ascites, esophageal and/or gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy) or with hepatic malignancy;
- Patients with chronic hepatitis C or non-viral chronic hepatitis (alcoholic, drug-induced, etc., excluding metabolic dysfunction-associated steatotic liver disease (MASLD));
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- History of alcohol abuse or inability to abstain from alcohol recently [Note: Alcohol abuse is defined as: ① daily ethanol consumption ≥40 g for males or ≥20 g for females for 5 consecutive years; OR ② history of heavy alcohol consumption (>80 g of ethanol per day) within the past 2 weeks. Ethanol (g) = volume of alcoholic beverage consumed (mL) × alcohol by volume (%) × 0.8];
- Patients with severe concurrent cardiovascular, pulmonary, renal, endocrine, neurological, or hematological diseases, or psychiatric disorders;
- Pregnant and/or lactating women;
- Participation in any other drug clinical trial within the past 3 months;
- Any condition that, in the investigator's judgment, may affect the subject's ability to provide informed consent or comply with the trial protocol, or participation that may affect the trial results or the subject's own safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Lungen Lu, Dr
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIIc Clinical Study Evaluating the Long-term Treatment of Hepatic Fibrosis in Chronic Hepatitis B With Hydronidone Capsules.
This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. The study consists of a Screening/Baseline Period (4 weeks) and a Dosing/Observation Period (planned duration of 5 years, including a 52-week primary treatment phase and a 208-week long-term treatment phase).
- Being tested
- Hydronidone (270mg), Hydronidone (Placebo Group)
- Keywords
- LIver Fibrosis in Chronic Hepatitis B
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydronidone (270mg)Drug
Dosage: 30 mg/capsule, three capsules taken three times daily, resulting in a total daily therapeutic dose of 270 mg. The medication is administered orally half an hour before meals.
Hydronidone (Placebo Group)Drug
Dosage: three capsules taken three times daily.The medication is administered orally half an hour before meals.
| Study group | Role | What they receive |
|---|---|---|
| Hydronidone Capsule Group (270 mg) | Experimental | Treatment Group Receives: Drug: Hydronidone (270mg) |
| Hydronidone Capsule Group (Placebo Group) | Placebo comparator | Placebo Group Receives: Drug: Hydronidone (Placebo Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinical Endpoint Events
The clinical endpoint event is a composite event, which includes progression to complications of decompensated cirrhosis (such as ascites, esophageal and gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy, etc.), hepatocellular carcinoma, liver transplantation, and liver disease-related death/all-cause death. The time of event occurrence is determined by whichever occurs first, and the occurrence of any of these events constitutes a clinical endpoint event.
Measured: From the first dose administration to the end of the treatment period (Week 261).
Secondary outcomes (10)
Annualized Incidence Rate of Clinical Endpoint Events
Measured: From the first dose administration to the end of the treatment period (Week 261).
The incidence rates of individual components of the clinical endpoint events
Measured: From the first dose administration to the end of the treatment period (Week 261).
The annualized incidence rates of individual components of the clinical endpoint events
Measured: From the first dose administration to the end of the treatment period (Week 261).
Change from baseline in liver stiffness measurement (LSM) by transient elastography (kPa) after treatment.
Measured: From the first dose administration to the end of the treatment period (Week 261).
Undetectable rate of Hepatitis B virus deoxyribonucleic acid (HBV DNA) after treatment (below the lower limit of detection).
Measured: From the first dose administration to the end of the treatment period (Week 261).
Magnitude of reduction in Hepatitis B virus deoxyribonucleic acid (HBV DNA) after treatment.
Measured: From the first dose administration to the end of the treatment period (Week 261).
Magnitude of improvement in alanine aminotransferase (ALT) levels after treatment.
Measured: From the first dose administration to the end of the treatment period (Week 261).
Normalization rate of improvement in alanine aminotransferase (ALT) levels after treatment.
Measured: From the first dose administration to the end of the treatment period (Week 261).
Normalization rate of improvement in aspartate aminotransferase (AST) levels after treatment.
Measured: From the first dose administration to the end of the treatment period (Week 261).
Magnitude of improvement in aspartate aminotransferase (AST) levels after treatment.
Measured: From the first dose administration to the end of the treatment period (Week 261).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start30 Jan 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412236
- Sponsor's protocol ID
- KDN-F351-202501
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIIc Clinical Study Evaluating the Long-term Treatment of Hepatic Fibrosis in Chronic Hepatitis B With Hydronidone Capsules.
- ClinicalTrials.gov ID
- NCT07412236
- Acronym / sponsor ID
- KDN-F351-202501
- Keywords
- LIver Fibrosis in Chronic Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,208 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Feb 2026 (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 is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. The study consists of a Screening/Baseline Period (4 weeks) and a Dosing/Observation Period (planned duration of 5 years, including a 52-week primary treatment phase and a 208-week long-term treatment phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydronidone Capsule Group (270 mg) | Experimental | Drug: Hydronidone (270mg)Treatment Group |
| Hydronidone Capsule Group (Placebo Group) | Placebo comparator | Drug: Hydronidone (Placebo Group)Placebo Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 to 65 years (inclusive of 18 and 65 years old at the time of signing the informed consent form), male or female;
- Documented history of chronic hepatitis B and/or positive for hepatitis B surface antigen (HBsAg) for ≥6 months;
- Treatment-naïve or treatment-experienced patients with chronic hepatitis B, defined as follows:
- ALT <8 × ULN;
- No use within 3 months prior to randomization of the following Chinese patent medicines that may have antifibrotic effects: Fuzhenghuayu Capsule (Tablet), Anluohuaxian Pill, Compound Biejia Ruangan Tablet, etc.;
Key exclusion criteria (11 listed)
- Total bilirubin (TBil) >3 × ULN, or 3 × ULN < ALT <8 × ULN with TBil >2 × ULN;
- Platelet count (PLT) ≤50 × 10⁹/L;
- Prothrombin activity (PTA) <50% or International Normalized Ratio (INR) >1.5;
- Imaging findings suggestive of a space-occupying lesion in the liver indicative of tumor, or alpha-fetoprotein (AFP) >100 μg/L even in the absence of specific signs of hepatocellular carcinoma;
- Patients with decompensated liver cirrhosis (complications including ascites, esophageal and/or gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy) or with hepatic malignancy;
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 |
|---|---|---|
| Hydronidone (270mg)Dosage: 30 mg/capsule, three capsules taken three times daily, resulting in a total daily therapeutic dose of 270 mg. The medication is administered orally half an hour before meals. | Drug | Hydronidone Capsule Group (270 mg) |
| Hydronidone (Placebo Group)Dosage: three capsules taken three times daily.The medication is administered orally half an hour before meals. | Drug | Hydronidone Capsule Group (Placebo Group) |
Primary outcome
Incidence of Clinical Endpoint Events
Time frame: From the first dose administration to the end of the treatment period (Week 261).
The clinical endpoint event is a composite event, which includes progression to complications of decompensated cirrhosis (such as ascites, esophageal and gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy, etc.), hepatocellular carcinoma, liver transplantation, and liver disease-related death/all-cause death. The time of event occurrence is determined by whichever occurs first, and the occurrence of any of these events constitutes a clinical endpoint event.
10 secondary outcomes
Annualized Incidence Rate of Clinical Endpoint Events
Time frame: From the first dose administration to the end of the treatment period (Week 261).
The incidence rates of individual components of the clinical endpoint events
Time frame: From the first dose administration to the end of the treatment period (Week 261).
The annualized incidence rates of individual components of the clinical endpoint events
Time frame: From the first dose administration to the end of the treatment period (Week 261).
Change from baseline in liver stiffness measurement (LSM) by transient elastography (kPa) after treatment.
Time frame: From the first dose administration to the end of the treatment period (Week 261).
Undetectable rate of Hepatitis B virus deoxyribonucleic acid (HBV DNA) after treatment (below the lower limit of detection).
Time frame: From the first dose administration to the end of the treatment period (Week 261).
Magnitude of reduction in Hepatitis B virus deoxyribonucleic acid (HBV DNA) after treatment.
Time frame: From the first dose administration to the end of the treatment period (Week 261).
Magnitude of improvement in alanine aminotransferase (ALT) levels after treatment.
Time frame: From the first dose administration to the end of the treatment period (Week 261).
Normalization rate of improvement in alanine aminotransferase (ALT) levels after treatment.
Time frame: From the first dose administration to the end of the treatment period (Week 261).
Normalization rate of improvement in aspartate aminotransferase (AST) levels after treatment.
Time frame: From the first dose administration to the end of the treatment period (Week 261).
Magnitude of improvement in aspartate aminotransferase (AST) levels after treatment.
Time frame: From the first dose administration to the end of the treatment period (Week 261).
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 17 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydronidone (270mg) in people with Liver Fibrosis and Liver Fibrosis in Chronic Hepatitis B, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site 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 15 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (+86-13501209210, zhangling@bjcontinent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinical Endpoint Events (time frame: From the first dose administration to the end of the treatment period (Week 261).). 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 17 Feb 2026.