PEG-IFN Alpha (Injection) in Chronic Hepatitis B Patients.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Hepatitis B VirusHealth Condition 2: K768- Other specified diseases of liver
- Registration Number
- CTRI/2017/07/008991
- Lead Sponsor
- Institute of liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 118
Inclusion Criteria
HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable.
ALT <40 IU/ml
No Advanced fibrosis[LSM <14 KPa]
TDF/ETV >1 year Viral Relapse after stopping NA will be defined as HBV DNA >2000IU/ml
Exclusion Criteria
HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection- HIV/HCV/HDV
Immunosuppressive therapy Renal failure S.Bilirubin >2mg/dl
Patient having neutropenia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained Virological Rsponse-HBV DNA2000IU/ml after stopping PEG IFN alphaTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFNTimepoint: 48 weeks;Loss of HBsAg after 48 weeks of PEG IFN alphaTimepoint: 48 weeks;Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy <br/ ><br>Timepoint: 1 year