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PEG-IFN Alpha (Injection) in Chronic Hepatitis B Patients.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/008991
Enrollment
120
Registered
2017-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Hepatitis B Virus Health Condition 2: K768- Other specified diseases of liver

Interventions

Intervention1: Peg IFN 2b: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks Control Intervention1: Not Applicable: Not Applicable

Sponsors

Institute of liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT No Advanced fibrosis[LSM TDF/ETV >1 year Viral Relapse after stopping NA will be defined as HBV DNA >2000IU/ml

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Sustained Virological Rsponse-HBV DNA2000IU/ml after stopping PEG IFN alphaTimepoint: 6 months—

Secondary

MeasureTime frame
End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFNTimepoint: 48 weeks;Loss of HBsAg after 48 weeks of PEG IFN alphaTimepoint: 48 weeks;Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy Timepoint: 1 year—

Countries

India

Contacts

Public ContactDr Karan Kumar

Institute of liver and Biliary Sciences

shivsarin@gmail.com011-46300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026