A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B
NCT ID: NCT04426968
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2021-06-18
2023-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hepalatide 2.1mg+Pegylated Interferon
Hepalatide 2.1mg s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks.
PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks
Hepalatide 2.1mg
2.1 mg/day subcutaneously (s.c.) for 24 week
Pegylated Interferon
180 ug/week subcutaneously (s.c.) for 28 week
Hepalatide 4.2mg+Pegylated Interferon
Hepalatide 4.2mg s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks.
PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks
Hepalatide 4.2mg
4.2mg/day subcutaneously (s.c.) for 24 week
Pegylated Interferon
180 ug/week subcutaneously (s.c.) for 28 week
Hepalatide 6.3mg+Pegylated Interferon
Hepalatide 6.3mg s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks.
PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks
Hepalatide 6.3mg
6.3mg/day subcutaneously (s.c.) for 24 week
Pegylated Interferon
180 ug/week subcutaneously (s.c.) for 28 week
placebo+Pegylated Interferon
Hepalatide placebo s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks.
PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks
placebo 2.1mg
2.1 mg/day subcutaneously (s.c.) for 24 week
placebo 4.2mg
4.2 mg/day subcutaneously (s.c.) for 24 week
placebo 6.3mg
6.3 mg/day subcutaneously (s.c.) for 24 week
Pegylated Interferon
180 ug/week subcutaneously (s.c.) for 28 week
Interventions
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Hepalatide 2.1mg
2.1 mg/day subcutaneously (s.c.) for 24 week
Hepalatide 4.2mg
4.2mg/day subcutaneously (s.c.) for 24 week
Hepalatide 6.3mg
6.3mg/day subcutaneously (s.c.) for 24 week
placebo 2.1mg
2.1 mg/day subcutaneously (s.c.) for 24 week
placebo 4.2mg
4.2 mg/day subcutaneously (s.c.) for 24 week
placebo 6.3mg
6.3 mg/day subcutaneously (s.c.) for 24 week
Pegylated Interferon
180 ug/week subcutaneously (s.c.) for 28 week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HBsAg or/and HBV DNA Positive for at least 6 months before Screening.
3. Subjects did not receive interferon treatment and did not receive nucleotide/nucleoside analogue within 6 months
4. HBeAg positive or negative
5. HBV DNA≥20,000 IU/ml (HBeAg positive) or HBV DNA≥2,000 IU/ml (HBeAg negative)
6. 2×ULN ≤ALT≤10×ULN
7. Serum total bilirubin\<2×ULN
8. 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.
9. Subjects must agree to use a highly effective contraception for 2 years , female subjects are not pregnant or breastfeeding
10. Subjects did not donate blood or as clinical trial subjects within 3 months before screening
11. Subjects have good compliance with the protocol
12. Subjects understood and agreed to sign the informed consent form.
Exclusion Criteria
2. Prothrombin time \> 1.2 × ULN, serum albumin \< 35 g / L
3. Severe liver fibrosis or cirrhosis: METAVIR score of liver biopsy is 4 points; or or Child-Pugh score\> 7
4. Hemocytopenia: neutrophil \< 1 × 10\^9 / L, platelet \< 50 × 10\^9 / L, hemoglobin \< 100g / L (female) or hemoglobin \< 110g / L (male) points
5. HAV,HCV,HDV,HEV or HIV infection
6. Pegylated interferon therapy is contraindicated
7. Allergic to interferon, Such as severe depression, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction and so on
8. severe retinopathy or eye disease(Eye diseases due to high blood pressure or diabetes, CMV retinitis, macular degeneration)
9. Positive for anti-HBV Pre-S1 antibody.
10. Hamilton Depression Scale (HAMD, 17 items) score \> 17 points
11. Female subjects pregnancy test positive
12. Other laboratories or auxiliary examinations are obviously abnormal
18 Years
60 Years
ALL
No
Sponsors
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Shanghai HEP Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Fusheng Wang
Role: PRINCIPAL_INVESTIGATOR
The fifth medical center of PLA
Locations
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The fifth medical center of PLA
Beijing, Beijing Municipality, China
Jilin Hepatobiliary Disease Hospital
Changchun, , China
The first hospital of Jilin University
Changchun, , China
Chizhou People's Hospital
Chizhou, , China
The First Hospital Affiliated to the Army Medical University
Chongqing, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
The Second Hospital of Nanjing
Nanjing, , China
Qingyuan People's Hospital
Qingyuan, , China
Shanghai Tongren Hospital
Shanghai, , China
The Sixth People's Hospital of Shenyang
Shenyang, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Henan Provincial Infectious Disease Hospital
Zhenzhou, , China
Countries
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Other Identifiers
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L47-HB-II-02
Identifier Type: -
Identifier Source: org_study_id
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