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Recruiting
NCT07709520
Study of GST-HG131&141 Tablets Compared With Placebo in Patients With Chronic Hepatitis B
Conditions: Chronic Hepatitis B
Sex: All
Ages: 35 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 80
Sponsor: Fujian Akeylink Biotechnology Co., Ltd.
Location: Beijing Friendship Hospital, Capital Medical University Beijing
Summary
A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131/GST-HG141 tablets in patients with chronic hepatitis B
Eligibility Criteria
Inclusion Criteria:
1. Able to sign the informed consent form and fully understand the test content, process and possible adverse reactions.
2. Males and females aged 35-65 years(inclusive),able to complete research in accordance with test plan requirements.
3. Participants who have no childbearing plan in a year,and must agree to voluntarily use the contraceptive methods specified in the protocol from screening to 6 months after the last dose of the study.
4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, with a body mass index (BMI) of 18-30 kg/m2 (inclusive).
5. Participants who have received stable NA therapy for more than half a year, and have maintained the NA regimen for ≥3 months prior to Screening.
6. HBV DNA concentration must be adequately suppressed, defined as At least two tests within 28 days of the screening period (more than 1 week apart) with HBV DNA lower than LLOQ .
7. HBeAg negative, 100≤HBsAg ≤1500 IU/mL, serum Alanine aminotransferase (ALT)\
Source: ClinicalTrials.gov (NCT07709520). StuddyBuddy aggregates publicly available trial information.