Last updated: November 12, 2021
Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.
Overall Status: Active - Not Recruiting
Phase
2
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
N/AClinical Study ID
NCT05133856
L47-HB-FIN-1
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 years ≤ age ≤ 60 years, both sexes.
- HBsAg (+) or HBV DNA (+) for ≧ 6 months
- HBeAg(-)
- on stable treatment for NAs for ≧ 2 years.
- HBV DNA <LLQD (lower limit of quantitative detection) at screening.
- ULN<ALT<10×ULN.
- total serum 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 last dose, andthat the woman is not pregnant or breastfeeding.
- have not participant in another clinical trial within 3 months
- have good compliance with the study protocol.
- the subject understands and agrees to sign the informed consent form
Exclusion
Exclusion Criteria:
- contraindications to pegylated interferon therapy, such as major depression,epilepsy, autoimmune disease, uncontrolled thyroid abnormal thyroid function, etc.
- clinical evidence of cirrhosis: e.g., definite cirrhosis on imaging such asabdominal ultrasound and CT; liver biopsy with Metavir fibrosis score of 4; clinicaldiagnosis of cirrhosis by the investigator.
- decompensated liver disease: PT > 1.2 x ULN, serum albumin < 35 g/L
- liver function Child-Pugh grade B-C or score >6
- any of the following.
- history of decompensated liver disease (ascites, hepatic encephalopathy, varicealhemorrhage, hepatorenal syndrome, etc.)
- history of severe heart disease (including unstable or uncontrolled heart diseasewithin 6 months)
- uncontrolled epilepsy, severe mental illness or history of severe mental illness
- history of organ transplantation.
- diabetes mellitus and hypertension that are not effectively controlled
- autoimmune diseases, immune-related extrahepatic manifestations (vasculitis,purpura, nodular arteritis, peripheral neuropathy and glomerulonephritis) ,thyroid disease, malignancy, and immunosuppressive therapy.
- with underlying diseases such as malignancy, severe infections, heart failure andchronic obstructive pulmonary disease, and other serious diseases diseases.
- History of alcohol or drug abuse.
- creatinine clearance <60mL/min.
- co-infected with hepatitis A, C, D or E virus, HIV infection.
- subjects who must be treated with anti-HBV nucleoside (acid) analogs other than TAFduring the treatment period.
- subjects who have used interferon within 6 months prior to the screening
- subjects with positive anti-HBV Pre-S1 antibody.
- Abnormal blood tests: white blood cell count < 3×10^9 /L, neutrophil count < 1.5×10^9/L , platelets < 60×10^9 /L .
- Positive pregnancy test in women.
- patients who are taking drugs prohibited by the test and cannot be discontinued
- patients with known allergy to the test drug or the underlying treatment drug
- other laboratory or ancillary tests are clearly abnormal and unsuitable forparticipation in the test.
Study Design
Total Participants: 30
Study Start date:
December 01, 2021
Estimated Completion Date:
June 30, 2024
Study Description
Connect with a study center
Shanghai Tong Ren Hospital
Shanghai, Shanghai 200050
ChinaSite Not Available

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