A Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection
Recruiting
Phase 1Interventional Study
Chronic Hepatitis B Virus (Hbv)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
9 (estimated)
Sponsor
Jiyan Liu · Other
Who this trial is looking for
This trial is looking for adults with chronic hepatitis B who have stable liver health. Participants will receive the WGc0201 vaccine to see if it can help improve their condition.
Are You a Good Fit for This Trial?
Must be takingNucleoside therapy
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with chronic hepatitis B.
I have been taking nucleoside therapy regularly for the last year.
My HBV-DNA viral load is below 100 IU/ml.
My HBsAg level is below 1500 IU/ml.
My body mass index (BMI) is between 18 and 32.
You may not be able to join if
I have liver conditions like cirrhosis or advanced fibrosis.
I have had significant liver issues or hepatitis D infection.
My liver enzyme levels or other blood test results are abnormal.
I have experienced severe liver failure symptoms before.
I have had any organ transplant other than corneal or hair transplant.
I have any active serious diseases like cancer or autoimmune disorders.
I have participated in another clinical trial in the last 3 months.
I have a history of alcohol or drug dependence.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-ar…
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adult males or females aged ≥18 to ≤65 years;
2. 18≤ BMI ≤32 kg/m2;
3. Diagnosis of chronic hepatitis B infection (HBsAg positive for more than 6 months and detectable at screening);
4. Received only nucleoside (acid) analog therapy in the 12 months prior to screening and are…
Inclusion Criteria:
1. Adult males or females aged ≥18 to ≤65 years;
2. 18≤ BMI ≤32 kg/m2;
3. Diagnosis of chronic hepatitis B infection (HBsAg positive for more than 6 months and detectable at screening);
4. Received only nucleoside (acid) analog therapy in the 12 months prior to screening and are still taking it regularly;
5. HBV-DNA viral load below 100 IU/ml;
6. HBsAg \<1500 IU/ml.
Exclusion Criteria:
1. Includes HIV, co-infection with HDV, and liver biopsy suggestive of cirrhosis or advanced fibrosis within 6 months prior to screening (Metavir activity level A3 and stages F3 and F4; Ishak stages 4-6);
2. If no liver biopsy was documented, a Fibroscan screen result \>9 kPa (or equivalent) or a FibroTest screen result \>0.48 and an APRI (Aspartate Aminotransferase to Platelet Ratio Index) \>1 within ≤6 months of screening.
3. Alanine aminotransferase \>3x ULN;
4. Internationally standardized ratio \> 1.5;
5. Albumin \<3.5 g/dl;
6. Direct bilirubin \> 1.5x ULN;
7. Platelet count \<100,000/μl;
8. History of hepatic failure (e.g., ascites, encephalopathy, or variceal bleeding) or prior hepatocellular carcinoma;
9. Diseases or past history of the following systems or serious illnesses that the investigator considers inappropriate for participation in this trial, such as: cardiovascular system: unstable or significant cardiovascular disease, such as angina pectoris, recent episode of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or ECG abnormality, etc.; respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.; endocrine and metabolic diseases: diabetes mellitus, thyroid disease poorly controlled by medication, etc.; others: autoimmune diseases, active tuberculosis, malignant diseases (e.g., tumors), history of neurological or psychiatric disorders, etc;
10. Subjects who have participated in any drug/device clinical study within 3 months prior to receiving the experimental drug.
11. History of organ transplantation (except corneal transplantation and hair transplantation).
12. Those with alcoholism (alcohol consumption for more than 5 years prior to the screening period, with alcohol content greater than 40g per day for men and 20g per day for women) or known drug dependence.
13. Subjects who have a birth plan or a plan to donate sperm or eggs during the screening period, during the trial, and for 6 months after the end of the trial or who are unwilling to use effective contraception.
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