To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.
1 other identifier
interventional
118
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2017
CompletedFirst Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2020
CompletedFebruary 5, 2020
October 1, 2019
2.5 years
April 19, 2017
February 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha
6 months
Secondary Outcomes (3)
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
Study Arms (1)
Peg IFN 2b
EXPERIMENTALPeg IFN 2b 1.5mcg/kg once every week for 48 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2017
First Posted
April 21, 2017
Study Start
March 17, 2017
Primary Completion
September 17, 2019
Study Completion
September 17, 2020
Last Updated
February 5, 2020
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share