A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
- Conditions
- Chronic Hepatitis B
- Interventions
- Registration Number
- NCT06990776
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. The purpose is to evaluate the efficacy and safety of TQA3605 tablets combined with entecavir in treatment-naive chronic HBV-infected subjects. A total of 215 subjects are required.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 215
- 18-65 years old (including boundary values), regardless of gender;
- Screening requires virological , clinical or pathological evidence of hepatitis B virus infection for more than 6 months; HBsAg positive, HBeAg positive, ALT≤5×ULN at screening;
- Never received nucleoside (acid) analog or interferon treatment, or previously received no more than 12 weeks of treatment but had discontinued therapy at least 6 months prior to the screening visit;
- Ability to communicate effectively with researchers and understand and comply with the requirements of this study, understand and sign the informed consent form;
- Male subjects with female partners who have fertility or female subjects of childbearing age are willing to voluntarily adopt effective contraceptive measures screening to within 3 months after leaving the group.
- Pregnant (positive pregnancy test) or lactating women.
- Co-infection with other viruses such as Hepatitis A Virus (HAV), Hepatitis C Virus (HCV), Hepatitis D Virus (HDV), Hepatitis E Virus (HEV), Human Immunodeficiency Virus (HIV), Syphilis, etc.;
- History of cirrhosis or evidence of significant fibrosis or cirrhosis before or during screening;
- History of hepatocellular carcinoma (HCC) or suspected HCC before or during screening.;
- History of malignant tumors within the past 5 years prior to screening, except for certain cancers that can be completely cured by surgical resection;
- Subjects with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, Wilson's disease, Gilbert syndrome, etc;
- Previous organ or bone marrow transplantation;
- Clinically significant abnormal laboratory test results at screening.
- Poorly controlled thyroid diseases or clinically significant thyroid dysfunction;
- Autoimmune diseases;
- Significant systemic or major illnesses other than liver disease.
- Any systemic anti-tumor or immunosuppressive therapy, or immunomodulatory therapy within 6 months prior to screening.
- High-dose systemic corticosteroids use within 3 months prior to screening;
- History of alcohol or drug abuse within the past year or excessive alcohol consumption.
- History of blood transfusion within 2 months prior to screening;
- History of allergy to investigational drug or its excipients.
- Previously participated in the clinical trial of hepatitis B core protein allosteric modulators;
- Participation in another clinical trial and receipt of an investigational drug within the following timeframes before the first dose in this study: 5 half-lives (if known) or twice the duration of the biological effect of the study treatment (if known), whichever is longer, or 90 days (if the half-life or duration is unknown);
- History or condition of cardiovascular disease;
- Any other condition deemed inappropriate for inclusion by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100mg TQA3605 tablets + entecavir (ETV) (PART A) TQA3605 Tablets Patients aged 30-65 years old group：TQA3605 tablets, 100mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks 100mg TQA3605 tablets + entecavir (ETV) (PART A) Entecavir dispersible tablets Patients aged 30-65 years old group：TQA3605 tablets, 100mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks 200mg TQA3605 tablets +ETV (PART A) TQA3605 Tablets Patients aged 30-65 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks 200mg TQA3605 tablets +ETV (PART A) Entecavir dispersible tablets Patients aged 30-65 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks TQA3605 tablets Placebo +ETV (PART A) TQA3605 tablets Placebo Patients aged 30-65 years old group： TQA3605 tablets placebo, once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. 200mg TQA3605 tablets +ETV (PART B) TQA3605 Tablets Patients aged 18-30 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. 200mg TQA3605 tablets +ETV (PART B) Entecavir dispersible tablets Patients aged 18-30 years old group：TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. TQA3605 tablets Placebo +ETV (PART B) TQA3605 tablets Placebo Patients aged 18-30 years old group：TQA3605 tablets Placebo taken once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks.
- Primary Outcome Measures
Name Time Method hepatitis B virus (HBV) DNA <10 IU/mL 48 weeks Percentage of subjects with HBV DNA below the lower limit of quantification (\<10 IU/mL) after 48 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Alanine aminotransferase(ALT)≤The upper limit of the normal reference value (ULN) 24weeks, 48 weeks, 72 weeks The rate of ALT normalization at weeks 24, 48, and 72 of treatment
Percentage of subjects with HBV DNA<10 IU/mL 12 weeks, 24 weeks, 36 weeks, 60 weeks, 72 weeks Percentage of subjects with HBV DNA\<10 IU/mL at week 12, 24, 36, 60, and 72
Percentage of HBV DNA<20 IU/mL 12 weeks, 24 weeks, 36 weeks, 48weeks, 60 weeks, 72 weeks Percentage of subjects with HBV DNA\<20 IU/mL at weeks 12, 24, 36, 48, 60, and 72 of treatment.
Percentage of subjects with HBeAg serologic clearance and/or serologic conversion 24weeks, 48 weeks, 72 weeks Percentage of subjects with HBeAg serologic clearance and/or serologic conversion
Virology breakthrough percentage 24weeks, 48 weeks, 72 weeks Percentage of subjects who experienced virological breakthroughs at weeks 24, 48, and 72 of treatment
Actual values of HBV markers and changes over time relative to baseline 12 weeks, 24 weeks, 36 weeks, 48 weeks, 72 weeks Actual values of HBsAg, HBeAg, HBV DNA, HBV RNA, and Hepatitis B core-related antigen (HBcrAg) at each visit time point and their changes over time relative to baseline.
Adverse events (AE) 72 weeks The incidence and severity of adverse events.
Steady state minimum concentration (Cmin,ss) 48 weeks Cmin,ss of TQA3605 and its metabolite
Trial Locations
- Locations (29)
Beijing Ditan Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Youan Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Southwest Hospital of AMU
🇨🇳ChongQing, Chongqing, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
NanFang Hospital
🇨🇳Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
The First Affiliated Hospital of GUANGXI Medical University
🇨🇳Nanning, Guangxi, China
Hebei Medical University Third Hospital
🇨🇳Shijiazhuang, Hebei, China
Zhengzhou No.6 peoples Hospital
🇨🇳Zhengzhou, Henan, China
Scroll for more (19 remaining)Beijing Ditan Hospital Capital Medical University🇨🇳Beijing, Beijing, ChinaMinghui Li, DoctorContact13693259096wuhm2000@sina.com