Back to resultsTo Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.
Primary Purpose
Hepatitis B
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Peg IFN 2b
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B
Eligibility Criteria
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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peg IFN 2b
Arm Description
Peg IFN 2b 1.5mcg/kg once every week for 48 weeks.
Outcomes
Primary Outcome Measures
Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha
Secondary Outcome Measures
Loss of HBsAg after 48 weeks of PEG IFN alpha
End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN
Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy
Full Information
NCT ID
NCT03123653
First Posted
April 19, 2017
Last Updated
February 1, 2020
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03123653
Brief Title
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.
Official Title
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
September 17, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peg IFN 2b
Arm Type
Experimental
Arm Description
Peg IFN 2b 1.5mcg/kg once every week for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Peg IFN 2b
Intervention Description
Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
Primary Outcome Measure Information:
Title
Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Loss of HBsAg after 48 weeks of PEG IFN alpha
Time Frame
48 weeks
Title
End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN
Time Frame
48 weeks
Title
Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.
We'll reach out to this number within 24 hrs