Chronic Hepatitis BPhase 2NCT06566248
A Clinical Trial to Evaluate the Efficacy and Safety of TQA3810 Tablets in Combination/Non Combination With Nucleoside (Acid) Analogues in Patients With Primary/Treated Chronic Hepatitis B
A Phase 2 study testing TQA3810 tablets+NUC in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 6 sites in China.
Trial summary
To evaluate the efficacy and safety of combined/uncombined nucleoside (acid) analogues of TQA3810 tablets. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TQA3810 tablets+NUC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 6 sitesChina
- Study dates
- 20 Mar 2024to Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 (including boundary values), male or female.
- Serum virological criteria: serum HBsAg positive for more than 6 months or evidence of chronic hepatitis B for more than 6 months. During the screening period, 100 IU/ml≤HBsAg quantification ≤10000 IU/ml.
- No obvious cirrhosis was found by the researchers.
- The subjects can communicate well with the researchers, understand and comply with the requirements of this study, and understand and sign the informed consent.
- The 12-lead electrocardiogram was normal, or there were no clinically significant abnormal values as assessed by the investigator.
- Treated patients must meet the following conditions:
Show all 11Show fewer
- Subjects must have received oral nucleoside (acid) therapy (entecavir/ Tenofovir alafenamide Fumarate tablets/Tenofovir Disoproxil Fumarate Tablets) for ≥6 months prior to screening and stable treatment regimen for ≥3 months prior to screening.
- Patients with medical history 6 months or more before enrollment had HBV DNA< the lower limit of normal detection, and hepatitis B virus (HBV) DNA<20 IU/mL was detected by Roche COBAS Taqman during the screening period.
- Newly treated patients need to meet the following conditions:
- At the time of screening, subjects had never received antiviral treatment for chronic hepatitis B (oral nucleoside drugs and interferon), or had received irregular antiviral treatment in the past, and had not received any antiviral treatment for chronic hepatitis B in the first 3 months of enrollment.
- HBV DNA≥2000 IU/mL(Roche COBAS Taqman).
Who cannot join
- Combined with other viral infections such as hepatitis A virus，hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus，syphilis (syphilis antibody positive by the researchers to determine the need for treatment). If hepatitis C virus (HCV) antibody positive, HCV RNA negative can not be excluded.
- Patients with significant fibrosis or cirrhosis before or at the time of screening: liver histopathological findings indicating Metavir F3 or F4 within 1 year before screening; FibroScan≥ 9.7 kPa 6 months before screening in treated patients and ≥ 12.4 kPa 6 months before screening in newly treated patients; Abdominal ultrasonography suggested suspected cirrhosis. Previous history of hepatic decompensation or screening period of hepatic decompensation, such as ascites, hepatic encephalopathy, esophageal and gastric varices bleeding, etc.
- Patients with a history of hepatocellular carcinoma (HCC) before or at the time of screening, or who may be at risk for HCC, such as suspicious nodules on imaging, or abnormal AFP (AFP>50ng/mL), should be excluded from HCC before enlisting.
- A history of malignant tumors within 5 years prior to screening, except for certain cancers that can be completely cured by surgical resection (such as skin basal cell carcinoma). Subjects being evaluated for active or suspected malignancy at the time of screening.
- Patients with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, hepatolenticular degeneration, etc.
- Have previously received organ transplantation and bone marrow transplantation.
Show all 14Show fewer
- Patients with uncontrolled thyroid disease.
- Eye diseases: including fundus lesions (cotton wool changes in the fundus with symptoms) and retinopathy.
- Autoimmune diseases include but are not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, psoriasis, autoimmune uveitis, etc.
- Current alcohol and drug abuse was determined by the investigator. Subjects with a history of excessive alcohol use. A history of excessive alcohol use was defined as alcohol consumption >210g per week for men and >140g for women in the past 12 months. Alcohol intake (g) = amount of alcohol consumed (ml) × alcohol degree % × 0.8.
- Blood transfusion ≤2 months before screening and/or blood donation ≤1 month before screening. Note: Subjects were not allowed to donate blood throughout the study period.
- Have a history of allergy to the experimental drug or its excipients;
- Female subjects are pregnant, breastfeeding or have positive pregnancy results during the screening period or during the test;
- Those that researchers believe should not be included.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210031
Jie Li, Doctor, 15863787910, lijier@sina.com
- Not yet recruiting
Shenyang Sixth People's Hospital
Shenyang, Liaoning, 110000
Fang Yang, Doctor, 18502460760, yangf0301@163.com
- Not yet recruiting
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, 215131
Chuanwu Zhu, Doctor, 13606202525, zhuchw@126.com
- Not yet recruiting
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 733099
Wenhua Zhang, Bachelor, 18993531188, 925944468@qq.com
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710061
Feng Ye, Doctor, 18991232860, Yefeng.jiaotong@163.com
- Not yet recruiting
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, 563000
Yawen Luo, Master, 18908523636, luoyw719@163.com
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase IIa Trial to Evaluate the Efficacy and Safety of Combined/Uncombined Nucleoside (Acid) Analogues of TQA3810 Tablets in Primary/Treated Patients With Chronic Hepatitis B
To evaluate the efficacy and safety of combined/uncombined nucleoside (acid) analogues of TQA3810 tablets.
- Conditions
- Chronic Hepatitis B
- Being tested
- TQA3810 tablets+NUC, Placebo+NUC
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQA3810 tablets+NUCDrug
TQA3810 is a novel, effective and highly selective small-molecule oral Toll-like receptors-8 agonist.
Placebo+NUCDrug
NUC:
Entecavir Dispersible Tablets, Inhibit viral replication; Tenofovir Disoproxil Fumarate Tablets, Nucleotide reverse transcriptase inhibitors; Tenofovir Alafenamide Fumarate Tablets, Inhibit HBV replication.
| Study group | Role | What they receive |
|---|---|---|
| Part A: TQA3810 tablets+NUC | Experimental | Part A: TQA3810 tablets+NUC：A total of 4 dose groups were set up, which were respectively TQA3810 tablets 0.1mg once a day, 0.2mg once every two days, 0.3mg twice a week and 0.2mg once a day combined with oral nucleoside (acid) drugs (NUC) group for 24 weeks. Receives: Drug: TQA3810 tablets+NUC |
| Part A: Placebo+NUC | Placebo comparator | Part A: Placebo+NUC: Placebo combined with oral nucleoside (acid) drugs (NUC) group was treated for 24 weeks. Receives: Drug: Placebo+NUC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during the study period
The study required collection of any adverse medical events, whether causally associated with the investigational drug or not, from the time the subject signed the informed consent to 28 days after the end of study medication or the initiation of other anti-HBV therapy (whichever came first).
Measured: Up to 52 months
Secondary outcomes (19)
Changes in serum HBsAg
Changes in serum HBsAg from baseline at 24 weeks
Measured: 24 weeks
HBV DNA level changes and drug resistance monitoring
Changes in HBV DNA levels from baseline and drug resistance monitoring.
Measured: 24 weeks
HBeAg level change
Changes in HBeAg levels from baseline.
Measured: 24 weeks
HBsAg clearance and/or serological conversion
Percentage of subjects with HBsAg clearance and/or serological conversion.
Measured: 24 weeks
HBeAg clearance and/or serological conversion
Percentage of subjects with HBeAg clearance and/or serological conversion
Measured: 24 weeks
HBsAg level decreased by ≥0.5log10 IU/ml
Proportion of subjects with HBsAg levels decreased at least 0.5log10 IU/ml
Measured: 24 weeks
Changes of HBV RNA and hepatitis B core-related antigen (HBcrAg) levels during treatment
Changes of HBV RNA and HBcrAg levels from baseline during treatment
Measured: 24 weeks
Peak time (Tmax)
Time to peak blood concentration after a single dose.
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Peak Concentration
The highest plasma drug concentration that can be achieved after medication.
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Area under blood concentration-time curve (AUC)
The amount of drug absorbed into the human circulation after a single dose can be estimated using the area under the blood concentration-time curve.
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Apparent volume of distribution (Vd/F)
When a drug reaches homeostasis in the body, the ratio of the amount of drug in the body to the blood concentration is called the apparent volume of distribution.
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Plasma clearance
How many milliliters of plasma can the kidneys completely clear in unit time (per minute).
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Elimination half-life time
The time it takes for the plasma concentration to drop by half
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Peaking Time
The time required to reach peak steady-state concentration after administration.
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Steady state maximum concentration
The highest blood concentration that occurs After stabilization
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Steady state minimal concentration
The lowest blood concentration that occurs after stabilization.
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Area under steady-state blood concentration-time curve
The area under the curve obtained with blood drug concentration as the vertical axis and time as the horizontal axis after administration.
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Evaluate whether TQA3810 will affect the heart rate-corrected QT interval (QTc) of newly treated/treated chronic hepatitis B patients
Evaluate whether TQA3810 will affect the QTc interval of newly treated/treated chronic hepatitis B patients
Measured: 24 weeks
Pharmacodynamic characteristics (IFN-γ, IL-1RA, CCL2, CCL4, CCL8, CCL11, CCL20, CXCL8, IL-12p70, IL-12p40, TNF-α, CRP)
Characteristics of IFN-γ, interleukin-1 receptor antagonist (IL-1RA), chemokine (C-C motif) ligand 2 (CCL2), Chemokine (C-C motif) ligands 4 (CCL4) , Chemokine (C-C motif) ligands 8 (CCL8), Chemokine (C-C motif) ligands 11 (CCL11), Chemokine (C-C motif) ligands 20 (CCL20), C-X-C motif chemokine ligand 8 (CXCL8), IL-12p70, IL-12p40, Tumor necrosis factor-α (TNF-α), C-reactive protein (CRP)
Measured: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start20 Mar 2024
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566248
- Sponsor's protocol ID
- TQA3810-IIa-01
- Status last verified
- Apr 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase IIa Trial to Evaluate the Efficacy and Safety of Combined/Uncombined Nucleoside (Acid) Analogues of TQA3810 Tablets in Primary/Treated Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT06566248
- Acronym / sponsor ID
- TQA3810-IIa-01
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Aug 2024 (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.
To evaluate the efficacy and safety of combined/uncombined nucleoside (acid) analogues of TQA3810 tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: TQA3810 tablets+NUC | Experimental | Drug: TQA3810 tablets+NUCPart A: TQA3810 tablets+NUC：A total of 4 dose groups were set up, which were respectively TQA3810 tablets 0.1mg once a day, 0.2mg once every two days, 0.3mg twice a week and 0.2mg once a day combined with oral nucleoside (acid) drugs (NUC) group for 24 weeks. |
| Part A: Placebo+NUC | Placebo comparator | Drug: Placebo+NUCPart A: Placebo+NUC: Placebo combined with oral nucleoside (acid) drugs (NUC) group was treated for 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-70 (including boundary values), male or female.
- Serum virological criteria: serum HBsAg positive for more than 6 months or evidence of chronic hepatitis B for more than 6 months. During the screening period, 100 IU/ml≤HBsAg quantification ≤10000 IU/ml.
- No obvious cirrhosis was found by the researchers.
- The subjects can communicate well with the researchers, understand and comply with the requirements of this study, and understand and sign the informed consent.
- The 12-lead electrocardiogram was normal, or there were no clinically significant abnormal values as assessed by the investigator.
Key exclusion criteria (14 listed)
- Combined with other viral infections such as hepatitis A virus，hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus，syphilis (syphilis antibody positive by the researchers to determine the need for treatment). If hepatitis C virus (HCV) antibody positive, HCV RNA negative can not be excluded.
- Patients with significant fibrosis or cirrhosis before or at the time of screening: liver histopathological findings indicating Metavir F3 or F4 within 1 year before screening; FibroScan≥ 9.7 kPa 6 months before screening in treated patients and ≥ 12.4 kPa 6 months before screening in newly treated patients; Abdominal ultrasonography suggested suspected cirrhosis. Previous history of hepatic decompensation or screening period of hepatic decompensation, such as ascites, hepatic encephalopathy, esophageal and gastric varices bleeding, etc.
- Patients with a history of hepatocellular carcinoma (HCC) before or at the time of screening, or who may be at risk for HCC, such as suspicious nodules on imaging, or abnormal AFP (AFP>50ng/mL), should be excluded from HCC before enlisting.
- A history of malignant tumors within 5 years prior to screening, except for certain cancers that can be completely cured by surgical resection (such as skin basal cell carcinoma). Subjects being evaluated for active or suspected malignancy at the time of screening.
- Patients with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, hepatolenticular degeneration, etc.
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 |
|---|---|---|
| TQA3810 tablets+NUCTQA3810 is a novel, effective and highly selective small-molecule oral Toll-like receptors-8 agonist. | Drug | Part A: TQA3810 tablets+NUC |
| Placebo+NUCNUC: Entecavir Dispersible Tablets, Inhibit viral replication; Tenofovir Disoproxil Fumarate Tablets, Nucleotide reverse transcriptase inhibitors; Tenofovir Alafenamide Fumarate Tablets, Inhibit HBV replication. | Drug | Part A: Placebo+NUC |
Primary outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during the study period
Time frame: Up to 52 months
The study required collection of any adverse medical events, whether causally associated with the investigational drug or not, from the time the subject signed the informed consent to 28 days after the end of study medication or the initiation of other anti-HBV therapy (whichever came first).
19 secondary outcomes
Changes in serum HBsAg
Time frame: 24 weeks
HBV DNA level changes and drug resistance monitoring
Time frame: 24 weeks
HBeAg level change
Time frame: 24 weeks
HBsAg clearance and/or serological conversion
Time frame: 24 weeks
HBeAg clearance and/or serological conversion
Time frame: 24 weeks
HBsAg level decreased by ≥0.5log10 IU/ml
Time frame: 24 weeks
Changes of HBV RNA and hepatitis B core-related antigen (HBcrAg) levels during treatment
Time frame: 24 weeks
Peak time (Tmax)
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Peak Concentration
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Area under blood concentration-time curve (AUC)
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Apparent volume of distribution (Vd/F)
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Plasma clearance
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Elimination half-life time
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Peaking Time
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Steady state maximum concentration
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Steady state minimal concentration
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Area under steady-state blood concentration-time curve
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Evaluate whether TQA3810 will affect the heart rate-corrected QT interval (QTc) of newly treated/treated chronic hepatitis B patients
Time frame: 24 weeks
Pharmacodynamic characteristics (IFN-γ, IL-1RA, CCL2, CCL4, CCL8, CCL11, CCL20, CXCL8, IL-12p70, IL-12p40, TNF-α, CRP)
Time frame: In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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. This study is not recruiting at the moment.
6 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 TQA3810 tablets+NUC in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 6 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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanyan Yu, Doctor (13901194223, yyy@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during the study period (time frame: Up to 52 months). 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 22 Aug 2024.