Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared Wi… (NCT06644417) | Clinical Trial Compass
CompletedPhase 2
Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Treatment of Chronic Hepatitis B Virus (HBV) Infection
China122 participantsStarted 2024-11-14
Plain-language summary
This study is a phase II multicenter, randomized, double-blind, placebo controlled study designed to evaluate the efficacy and safety in LLV subjects and demonstrate that TQA3605 tablets combined with oral NAs drugs can improve the efficacy and safety of LLV subjects compared with oral NAs drug.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 18-65 (including boundary values), male or female.
* At the time of screening, etiological or clinical or pathological evidence of hepatitis B virus infection has been more than 1 year; HBsAg positive, 10 IU/mL \<HBV DNA≤2000 IU/mL, ALT≤3×ULN (upper limit of normal); No obvious cirrhosis was found by the researchers.
* Continuous administration of any nucleoside (acid) analogues for more than 1 year and a stable regimen of ≥6 months prior to screening.
* Able to communicate well with researchers, understand and comply with the requirements of the study, understand and sign the informed consent.
* Male subjects with fertile female partners or female subjects of childbearing age were willing to voluntarily take effective contraceptive measures within 3 months after screening.
Exclusion Criteria:
* Pregnant (positive pregnancy test) or breastfeeding women.
* Co-infection with other viruses such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus, syphilis.
* A history of cirrhosis or evidence of significant fibrosis or cirrhosis at pre-screening/screening time.
* The subject had a history of hepatocellular carcinoma (HCC) before or at the time of screening, or was suspected of HCC.
* A history of malignant tumors within 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 limite…
What they're measuring
1
HBV DNA (Hepatitis B virus Deoxyribonucleic Acid)
Timeframe: 24 weeks
Trial details
NCT IDNCT06644417
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.