A Phase II Study of Hepalatide in Subjects With HBeAg-positive Chronic Hepatitis B

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 HBeAg-positive Chronic Hepatitis B

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.
• Treatments: Interferons

Criteria

Inclusion Criteria:

1. Age from 18 to 60 years inclusively at the time of signing Informed Consent Form.

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

5. HBV DNA≥20,000 IU/ml

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:

1. Decompensated liver disease: direct bilirubin > 1.2 × ULN, prothrombin time > 1.2 × ULN, serum albumin < 35 g / L

2. Hemocytopenia: neutrophil < 1 × 10^9 / L, platelet < 50 × 10^9 / L, hemoglobin < 100g / L (female) or hemoglobin < 110g / L (male)

3. Severe liver fibrosis or cirrhosis: METAVIR score of liver biopsy is 4 points; or LSM score of FibroScan ≥ 12.17 kPa

4. HAV,HCV,HDV,HEV or HIV infection

5. Allergic to interferon

6. Positive for anti-HBV Pre-S1 antibody.

7. Hamilton Depression Scale (HAMD, 17 items) score > 17 points

8. Child-Pugh score> 6 points

9. Female subjects pregnancy test positive

10. Other laboratories or auxiliary examinations are obviously abnormal