To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.
NCT ID: NCT03123653
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
118 participants
INTERVENTIONAL
2017-03-17
2020-09-17
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Peg IFN 2b
Peg IFN 2b 1.5mcg/kg once every week for 48 weeks.
Peg IFN 2b
Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
Interventions
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Peg IFN 2b
Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Other Identifiers
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ILBS-HBV-01
Identifier Type: -
Identifier Source: org_study_id
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