A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive HBeAg-positive Subjects With Chronic HBV Infection
| Registry | NCT06990776 |
|---|---|
| Status | Withdrawn - Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns. |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry) |
| Conditions | Chronic Hepatitis B |
| Interventions | TQA3605 tablets Placebo, TQA3605 Tablets, Entecavir dispersible tablets (Drug) |
| Dates | start 2025-07-09, primary completion 2025-07-17, completion 2025-07-17, first posted 2025-05-25, last updated 2025-08-03 |
| Locations | 29 sites in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Hepatitis B All trials of TQA3605 tablets Placebo All trials of TQA3605 Tablets
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 100mg TQA3605 tablets + entecavir (ETV) (PART A) | Experimental | Drug: TQA3605 Tablets; Drug: 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) | Experimental | Drug: TQA3605 Tablets; Drug: 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) | Placebo comparator | Drug: 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) | Experimental | Drug: TQA3605 Tablets; Drug: 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) | Placebo comparator | Drug: 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. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Beijing, Beijing Municipality | China | |
| Beijing Youan Hospital,Capital Medical University | Beijing, Beijing Municipality | China | |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing, Chongqing Municipality | China | |
| The Southwest Hospital of AMU | Chongqing, Chongqing Municipality | 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 | |
| Henan Provincial People's Hospital | Zhengzhou, Henan | China | |
| The First Hospital of Changsha | Changsha, Hunan | China | |
| Jiangsu Provincial People's Hospital | Nanjing, Jiangsu | China | |
| The Second Hospital of Nanjing | Nanjing, Jiangsu | China | |
| Naniing Drum Tower Hospital | Nanjing, Jiangsu | China | |
| The Fifth People's Hospital of Suzhou | Suzhou, Jiangsu | China | |
| The Fifth People's Hospital of Wuxi | Wuxi, Jiangsu | China | |
| Zhenjiang Third People's Hospital | Zhenjiang, Jiangsu | China | |
| The First Affiliated Hospital of Nanchang University | Nanchang, Jiangxi | China | |
| The First Hospital of Jilin University | Changchun, Jilin | China | |
| Shengjing Hospital Affiliated to China Medical University | Shenyang, Liaoning | China | |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an, Shaanxi | China | |
| Xi'an Jiaotong University Second Affiliated Hospital | Xi'an, Shaanxi | China | |
| The Second Hospital of Shandong University | Jinan, Shandong | China | |
| Shandong Provincial Clinical Center for Public Health | Jinan, Shandong | China | |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai, Shanghai Municipality | China | |
| Shanghai Tongren Hospital | Shanghai, Shanghai Municipality | China | |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi, Xinjiang | China | |
| Yiwu Central Hospital | Yiwu, Zhejiang | China |