Hepatitis B Clinical Trial
Official title:
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy
- 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
n/a
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