Phase
Condition
Hepatitis
Liver Disorders
Hepatitis B
Treatment
Placebo of Hepalatide
Tenofovir Alafenamide Tablets
Pegylated Interferon alfa 2a
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
HBsAg or/and HBV DNA Positive for at least 6 months
HBeAg negative
Received NAs stabilization therapy for at least 2 years
ALT≤ 2×ULN
HBV DNA< LLQD(lower limit of quantitative detection) in Screening
Serum total bilirubin<2×ULN
no childbirth plan within 2 years and agree to take effective contraceptivemeasures throughout the treatment period and within 3 months after the lastdose, and that the woman is not pregnant or breastfeeding.
have not participant in another clinical trial within 3 months before screening
Subjects have good compliance with the protocol
Subjects understood and agreed to sign the informed consent form.
Exclusion
Exclusion Criteria:
Contraindications of Peginterferon such as depressive disorder, epilepsy,autoimmune diseases, uncontrolled thyroid dysfunction, etc
Subjects with cirrhosis, e.g., definite cirrhosis on imaging such as abdominalultrasound and CT; liver biopsy with Metavir fibrosis score = 4; clinicaldiagnosis of cirrhosis by the investigator.
Decompensated liver disease
Child-Pugh score of B-C or over 6 points.
Subjects with any of the following circumstances
History of decompensated liver disease
History of serious heart disease (including unstable or uncontrolled heart diseasewithin 6 months)
Uncontrolled seizures, severe psychiatric disorders, or a history of psychiatricdisorders
with history of organ transplantation
with poorly controlled diabetes and hypertension
with autoimmune diseases, immune-related extrahepatic manifestations, thyroiddisease, malignant tumors, or in immunosuppressive therapy
underlying diseases such as malignant tumor, severe infection, heart failure andchronic obstructive pulmonary disease and other serious diseases.
with history of alcohol or drug abuse
Creatinine clearance <60 mL/min.
HAV, HCV, HDV, HEV or HIV co-infection
Subjects who must be treated with Nucleosides (acids) other than TAF duringtreatment period
Subjects who used interferon in the 6 months prior to the screening period
Positive for anti-HBV Pre-S1 antibody.
Hemocytopenia: White blood cells < 3 × 10^9 / L, neutrophil < 1.5 × 10^9 / L,platelet < 60 × 10^9 / L,
Female subjects pregnancy test positive
known to be allergic to the investigational drug or the underlying treatmentdrug
Other laboratories or auxiliary examinations are obviously abnormal
Study Design
Study Description
Connect with a study center
Shanghai East Hospital
Shanghai, Shanghai 200127
ChinaSite Not Available
Shanghai Tong Ren Hospital
Shanghai, Shanghai 200050
ChinaSite Not Available
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