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

This study is currently recruiting participants.
Verified April 2017 by Institute of Liver and Biliary Sciences, India
Sponsor:
ClinicalTrials.gov Identifier:
NCT03123653
First Posted: April 21, 2017
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
  Purpose
  • Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year
  • Study design:Prospective,Interventional (single arm study)
  • Study period: 2 year: January 2017 to December 2018
  • Sample size: All the patients during the study period fulfilling the inclusion criteria will be included.
  • Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
  • Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline,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

Condition Intervention
Hepatitis B Drug: Peg IFN 2b

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Sustained Virological Rsponse-HBV DNA<2000IU/ml after stopping PEG IFN alpha [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Loss of HBsAg after 48 weeks of PEG IFN alpha [ Time Frame: 48 weeks ]
  • End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN [ Time Frame: 48 weeks ]
  • Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy [ Time Frame: 1 year ]

Estimated Enrollment: 120
Actual Study Start Date: April 7, 2017
Estimated Study Completion Date: April 25, 2019
Estimated Primary Completion Date: April 25, 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Peg IFN 2b
    Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Viral Relapse after stopping NA will be defined as HBV DNA>2000IU/ml

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123653


Contacts
Contact: Dr Karan Kumar, MD 01146300000 Karanbjmc93@gmail.com

Locations
India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
  More Information

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03123653     History of Changes
Other Study ID Numbers: ILBS-HBV-01
First Submitted: April 19, 2017
First Posted: April 21, 2017
Last Update Posted: July 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections