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A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B
Led by Fujian Akeylink Biotechnology Co., Ltd. · Updated on 2025-03-05
45
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, double-blind, placebo-controlled Phase IIa clinical trial to assess the safety and efficacy of GST-HG131 tablets in adults aged 35 to 65 years with chronic hepatitis B. Participants must be on stable nucleos(t)ide analog therapy and meet specific health criteria to join this study. Participants will be randomly assigned in a 4:1 ratio to receive one of two doses of GST-HG131 or a matching placebo. The treatment periods include 28 days for each dose cohort and a 12-week period for a combined dose group, all while continuing their existing nucleos(t)ide analog therapy. The trial evaluates changes in hepatitis B surface antigen levels over these periods. Throughout the study, participants will undergo regular monitoring including blood tests to measure hepatitis B virus levels and safety assessments for adverse events. Researchers will track changes from baseline in HBsAg levels up to 56 days or 16 weeks, depending on cohort, alongside monitoring for any side effects or serious adverse events. The study aims to gather detailed data on the drug's impact and safety profile during the treatment and follow-up periods.
CONDITIONS
Brief Title
A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to sign informed consent and understand the study process and possible side effects
- Males and females aged 35 to 65 years able to complete the study as planned
- No plan to have children in the next year and agree to use specified contraception from screening to 6 months after last dose
- Male weight at least 50 kg; female weight at least 45 kg; BMI between 18.0 and 35.0 kg/m2
- On stable nucleos(t)ide analog therapy for more than 6 months and maintained regimen for at least 3 months before screening
- At least two HBV DNA tests within 28 days before screening showing levels below the lower limit of quantification
- HBeAg negative, HBsAg quantitative levels 100 to 1500 IU/mL, and serum ALT less than 1 times the upper limit of normal during screening
- Vital signs, physical examination, and ECG results without clinically significant abnormalities
- Able to communicate well with clinical staff and comply with study requirements
You will not qualify if you...
- History of allergy to study drug ingredients or excipients
- Unable to tolerate blood draws or history of fainting during venipuncture
- Major trauma or surgery within 3 months before screening or planned surgery during the study
- Blood donation or loss greater than 400 mL within 3 months before screening, or greater than 200 mL within 1 month
- History of alcohol or drug abuse or dependence
- Participation in other clinical trials within 3 months prior to study drug administration
- Use of hepatitis B drugs other than nucleos(t)ide analogs within 1 year prior to administration
- Use of systemic immunosuppressants, immunomodulators (excluding interferon), or cytotoxic drugs within 6 months before screening; live vaccine within 1 month before screening
- Significant acute or chronic liver disease from non-HBV causes deemed unsuitable
- History of cirrhosis or decompensated hepatitis B cirrhosis with complications
- Malignancy within 5 years prior to screening except certain skin and cervical cancers
- Gastrointestinal diseases affecting drug absorption or severe gastrointestinal symptoms at screening
- Suspected or confirmed acute infections within 2 weeks before randomization
- Laboratory abnormalities including low blood counts, high bilirubin, low albumin, impaired kidney function, or prolonged blood clotting
- Elevated AFP levels or imaging suggesting possible liver cancer
- Positive tests for hepatitis C, syphilis, or HIV
- Breastfeeding or positive pregnancy test at screening or baseline
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days for Cohorts 1 and 2; 12 weeks for Cohort 3
Participants receive repeated doses of GST-HG131 or placebo while continuing stable nucleos(t)ide analog therapy.
Regular visits throughout treatment period
Duration - Up to 56 days for Cohorts 1 and 2; up to 16 weeks for Cohort 3
Participants are monitored for safety and efficacy after treatment completion.
Visits continuing post-treatment as scheduled
Trial Site Locations
Total: 1 location
1
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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