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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
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Start Date
March 17, 2017
Primary Completion Date
September 17, 2019
Completion Date
September 17, 2020
Last Updated
February 5, 2020
118
ACTUAL participants
Peg IFN 2b
DRUG
Lead Sponsor
Institute of Liver and Biliary Sciences, India
NCT07024641
NCT06671093
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07275554