Status:
COMPLETED
A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B
Lead Sponsor:
Shanghai HEP Pharmaceutical Co., Ltd.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects with Chronic Hepatitis ...
Detailed Description
The study is a 4-arm parallel design, randomized, double-blind, placebo-controlled, multicenter, dose-effect relationship, phase II clinical trial. The study is designed to assess efficacy and safety ...
Eligibility Criteria
Inclusion
- Age from 18 to 60 years inclusively at the time of signing Informed Consent Form.
- HBsAg or/and HBV DNA Positive for at least 6 months before Screening.
- Subjects did not receive interferon treatment and did not receive nucleotide/nucleoside analogue within 6 months
- HBeAg positive or negative
- HBV DNA≥20,000 IU/ml (HBeAg positive) or HBV DNA≥2,000 IU/ml (HBeAg negative)
- 2×ULN ≤ALT≤10×ULN
- Serum total bilirubin\<2×ULN
- Subjects had no history of decompensated liver disease（Ascites, jaundice, hepatic encephalopathy, varicose hemorrhage）, serious heart disease (including unstable or uncontrolled heart disease within 6 months),serious mental illness (especially depression),organ transplantation .subjects have no uncontrolled epilepsy, mental illness, diabetes and hypertension,no autoimmune disease, immune related extrahepatic manifestations (vasculitis, purpura, nodular arteritis, peripheral neuropathy and glomerulonephritis), thyroid disease, malignant tumor, immunosuppressive therapy; no basic diseases and other serious diseases such as serious infection, retinal disease, heart failure and chronic obstructive pulmonary disease; no alcohol and drug abuse.
- Subjects must agree to use a highly effective contraception for 2 years , female subjects are not pregnant or breastfeeding
- Subjects did not donate blood or as clinical trial subjects within 3 months before screening
- Subjects have good compliance with the protocol
- Subjects understood and agreed to sign the informed consent form.
Exclusion
- Decompensated liver disease: direct bilirubin \> 1.2 × ULN,
- Prothrombin time \> 1.2 × ULN, serum albumin \< 35 g / L
- Severe liver fibrosis or cirrhosis: METAVIR score of liver biopsy is 4 points; or or Child-Pugh score\> 7
- Hemocytopenia: neutrophil \< 1 × 10\^9 / L, platelet \< 50 × 10\^9 / L, hemoglobin \< 100g / L (female) or hemoglobin \< 110g / L (male) points
- HAV,HCV,HDV,HEV or HIV infection
- Pegylated interferon therapy is contraindicated
- Allergic to interferon, Such as severe depression, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction and so on
- severe retinopathy or eye disease(Eye diseases due to high blood pressure or diabetes, CMV retinitis, macular degeneration)
- Positive for anti-HBV Pre-S1 antibody.
- Hamilton Depression Scale (HAMD, 17 items) score \> 17 points
- Female subjects pregnancy test positive
- Other laboratories or auxiliary examinations are obviously abnormal
Key Trial Info
Start Date :
June 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04426968
Start Date
June 18 2021
End Date
November 29 2023
Last Update
January 27 2025
Active Locations (12)
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1
The fifth medical center of PLA
Beijing, Beijing Municipality, China, 100039
2
Jilin Hepatobiliary Disease Hospital
Changchun, China
3
The first hospital of Jilin University
Changchun, China
4
Chizhou People's Hospital
Chizhou, China