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

Korábbi kezelés

• Pegylated interferon therapy is contraindicated

Más betegség

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

Laborértékek

• Decompensated liver disease: direct bilirubin \> 1.2 × ULN,
• Prothrombin time \> 1.2 × ULN, serum albumin \< 35 g / L
• Hemocytopenia: neutrophil \< 1 × 10\^9 / L, platelet \< 50 × 10\^9 / L, hemoglobin \< 100g / L (female) or hemoglobin \< 110g / L (male) points

Egyéb

• Severe liver fibrosis or cirrhosis: METAVIR score of liver biopsy is 4 points; or or Child-Pugh score\> 7
• Hamilton Depression Scale (HAMD, 17 items) score \> 17 points
• Female subjects pregnancy test positive
• Other laboratories or auxiliary examinations are obviously abnormal

• 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.