Actively Recruiting
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
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 study details and risks
- Male or female aged 35 to 65 able to follow study requirements
- No plans to have children within the next year and agree to use specified contraception from screening to 6 months after last dose
- Male weight at least 50 kg and female weight at least 45 kg; BMI between 18.0 and 35.0 kg/m2
- On stable nucleoside analogue 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 lower limit of quantification
- HBeAg negative, HBsAg quantitative ≤1500 IU/mL, serum ALT less than 1 times upper limit of normal during screening
- Vital signs, physical exam, and ECG results during screening and baseline have no clinically significant abnormalities
- Able to communicate well with clinical staff and complete the trial as required
You will not qualify if you...
- Allergy to any ingredient or excipient of the study drug
- Unable to tolerate venous blood collection or history of fainting from needles or blood draws
- Major trauma or surgery within 3 months before screening or planned surgery during study
- Blood donation or loss ≥400 mL within 3 months before screening, or ≥200 mL within 1 month before screening, or blood transfusions
- History of alcohol or drug abuse or dependence
- Participation in other drug or medical device clinical trials within 3 months before dosing
- Use of hepatitis B drugs other than nucleoside analogues within 1 year before dosing
- Use of systemic immunosuppressants, immunomodulators (excluding interferon), cytotoxic drugs within 6 months before screening, or live attenuated vaccines within 1 month before screening
- Significant acute or chronic liver disease from causes other than HBV judged unsuitable for study
- History of cirrhosis diagnosed by pathology or endoscopy
- Decompensated hepatitis B cirrhosis or related complications
- Cancer or history of cancer within 5 years except certain cured skin or cervical cancers
- Impaired gastrointestinal function or disease affecting drug absorption, or moderate to severe gastrointestinal symptoms at screening
- Suspected or confirmed acute infections within 2 weeks before randomization
- Low platelet, white blood cell, or neutrophil counts; high bilirubin; low albumin; low creatinine clearance or high INR
- Elevated serum AFP or imaging indicating possible liver cancer
- Positive tests for hepatitis C, syphilis, or HIV
- Breastfeeding or positive pregnancy test at screening or baseline
- Investigator judgment that participation is not suitable
AI-Screening
AI-Powered Screening
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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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