NCT03123653

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Peg IFN 2b	Peg IFN 2b 1.5mcg/kg once every week for 48 weeks

Timeline

• Start date: 2017-03-17
• Primary completion: 2019-09-17
• Completion: 2020-09-17
• First posted: 2017-04-21
• Last updated: 2020-02-05

Locations

1 site across 1 country: India