Status:
WITHDRAWN
A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06990776
Start Date
July 9 2025
End Date
July 17 2025
Last Update
August 3 2025
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100015
2
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100069
3
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
4
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, China, 400038