A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chroni… (NCT06990776) | Clinical Trial Compass
WithdrawnPhase 2
A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
Stopped: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
China0Started 2025-07-09
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 liv…
What they're measuring
1
hepatitis B virus (HBV) DNA <10 IU/mL
Timeframe: 48 weeks
Trial details
NCT IDNCT06990776
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.