Actively Recruiting
A Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection
Led by Jiyan Liu · Updated on 2026-04-07
9
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
J
Jiyan Liu
Lead Sponsor
W
West China Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Existing nucleoside analogues (NAs) and interferon therapy for chronic hepatitis B (CHB) have limitations, including drug resistance, low HBsAg clearance rates, and irreversible immunosuppression. Therapeutic vaccines, by activating virus-specific T cells and B cells, hold promise for achieving functional cure (HBsAg clearance + sustained HBV DNA negativity). This study is an open-label, single-arm, dose-escalation Phase I clinical trial. The study population consists of patients with chronic hepatitis B virus infection who have achieved virological stability following standard antiviral therapy. Phase I (dose exploration): three dose groups, with three patients per group. The primary objective is to observe and evaluate the safety of the WGc0201 vaccine in the study population (incidence and severity of adverse events).
CONDITIONS
Official Title
A Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Body mass index between 18 and 32 kg/m2
- Confirmed chronic hepatitis B infection with HBsAg positive for more than 6 months
- Receiving only nucleoside (acid) analog therapy for at least 12 months prior and continuing it regularly
- HBV-DNA viral load below 100 IU/ml
- HBsAg level less than 1500 IU/ml
You will not qualify if you...
- Co-infection with HIV or HDV
- Liver biopsy showing cirrhosis or advanced fibrosis within 6 months prior
- Fibroscan >9 kPa or FibroTest >0.48 and APRI >1 if no biopsy
- Alanine aminotransferase over 3 times the upper limit of normal
- Internationally standardized ratio over 1.5
- Albumin level below 3.5 g/dl
- Direct bilirubin over 1.5 times the upper limit of normal
- Platelet count below 100,000/μl
- History of hepatic failure or hepatocellular carcinoma
- Serious cardiovascular, respiratory, endocrine, autoimmune, infectious, malignant, neurological, or psychiatric diseases
- Participation in any drug or device clinical study within 3 months prior
- History of organ transplantation except corneal or hair
- Alcoholism or drug dependence
- Plans for pregnancy, sperm or egg donation during the study period and 6 months after, or unwillingness to use contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
H
Hong-Shuai Li, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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