Overview

To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.

Status:
Unknown status
Trial end date:
2020-09-17
Target enrollment:
Participant gender:
Summary
- Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year - Study design:Prospective,Interventional (single arm study) - Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years - Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks - Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month - Adverse effects: The most frequently reported side effects of IFN-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\1000/mm3 and thrombocytopenia \500,000/ mm3 are not common unless patients already have cirrhosis
Phase:
N/A
Details
Lead Sponsor:
Institute of Liver and Biliary Sciences, India