Actively Recruiting
To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment
Led by Fujian Akeylink Biotechnology Co., Ltd. · Updated on 2026-01-23
526
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GST-HG141 in patients with chronic hepatitis B who have an inadequate response to antiviral drug treatment.
CONDITIONS
Official Title
To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female individuals aged 18-70 years (inclusive)
- Male weight at least 50 kg, female weight at least 45 kg, with a body mass index (BMI) between 18 and 35 kg/m2 (inclusive)
- Have been continuously taking nucleoside analogues (entecavir, tenofovir disoproxil fumarate, emivirofavir, or propivirofavir) for more than one year, with less than a one-month break in the past year
- Have maintained the same nucleoside analogue monotherapy for more than 3 months before screening
- HBeAg positive with detectable serum HBV DNA by high-sensitivity PCR greater than 50 IU/mL
- Alanine aminotransferase (ALT) level at screening is less than or equal to 5 times the upper limit of normal
- Male participants with a fertile female partner or female participants of childbearing age willing to use effective contraception from screening until 28 days after study completion
- Able to provide informed consent and complete the study as required
You will not qualify if you...
- History of life-threatening severe allergic reactions or allergy to study drug components
- Use of cytochrome P450 enzyme 3A4 inhibitors, inducers, or substrates within 28 days prior to screening
- Use of systemic immunosuppressants, immunomodulators (interferon discontinued for more than 12 months), or cytotoxic drugs within 6 months prior to screening; or live attenuated vaccine within 1 month prior to screening
- Presence of acute infections requiring treatment before randomization
- Acute or chronic liver diseases not caused by hepatitis B making participation unsuitable
- History or current diagnosis of cirrhosis or decompensated cirrhosis including complications like hepatic encephalopathy or variceal bleeding
- Primary liver cancer or other malignancies in past 5 years except certain skin or cervical cancers
- Gastrointestinal diseases affecting oral medication absorption or significant gastrointestinal symptoms at screening
- Severe diseases of circulatory, respiratory, urinary, hematologic, metabolic, immune, psychiatric, neurological, or renal systems making participation unsuitable
- Major trauma or surgery within 3 months prior or planned during study
- Low platelet count, low white blood cell or neutrophil count, high bilirubin, low albumin, reduced kidney function, or abnormal blood clotting tests
- Positive for hepatitis C antibody, HIV antigen/antibody, or syphilis with positive confirmatory test
- History of sustained alcohol abuse in past 3 years
- History of drug dependence or substance abuse
- Participation in other investigational drug or device trials within 3 months prior to screening
- Women who are breastfeeding or pregnant
- Any other reasons deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shulan(Hangzhou) Hospital
Hangzhou, Zhejiang, China, 310011
Actively Recruiting
Research Team
Y
Yan wenhao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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