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

Not Applicable

• Conditions: Hepatitis B
• Interventions: Drug: Peg IFN 2b

• Registration Number: NCT03123653
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-17
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-21
• Primary Completion: 2019-09-17
• Status Verified: 2019-10
• Last Update Submitted: 2020-02-01
• Last Update Posted: 2020-02-05
• Study Completion: 2020-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU

Exclusion Criteria

• HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection- HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peg IFN 2b	Peg IFN 2b	Peg IFN 2b 1.5mcg/kg once every week for 48 weeks.

Primary Outcome Measures

Name	Time	Method
Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha	6 months

Secondary Outcome Measures

Name	Time	Method
Loss of HBsAg after 48 weeks of PEG IFN alpha	48 weeks
End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN	48 weeks
Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy	1 year

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India