A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B
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 B
1 other identifier
interventional
96
1 country
12
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 B
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2021
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
June 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2023
CompletedJanuary 27, 2025
December 1, 2022
2.4 years
June 9, 2020
January 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
virological response
24weeks
Secondary Outcomes (1)
HBV DNA down from baseline
24weeks
Other Outcomes (8)
Virological suppression
24weeks
No response
24weeks
Partial virological response
24weeks
- +5 more other outcomes
Study Arms (4)
Hepalatide 2.1mg+Pegylated Interferon
EXPERIMENTALHepalatide 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 4.2mg+Pegylated Interferon
EXPERIMENTALHepalatide 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 6.3mg+Pegylated Interferon
EXPERIMENTALHepalatide 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
placebo+Pegylated Interferon
ACTIVE COMPARATORHepalatide 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
Interventions
2.1 mg/day subcutaneously (s.c.) for 24 week
4.2mg/day subcutaneously (s.c.) for 24 week
6.3mg/day subcutaneously (s.c.) for 24 week
180 ug/week subcutaneously (s.c.) for 28 week
Eligibility Criteria
You may qualify if:
- 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)
- ×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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
The fifth medical center of PLA
Beijing, Beijing Municipality, 100039, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fusheng Wang
The fifth medical center of PLA
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 11, 2020
Study Start
June 18, 2021
Primary Completion
November 1, 2023
Study Completion
November 29, 2023
Last Updated
January 27, 2025
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share