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

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ClinicalTrials.gov Identifier: NCT03123653
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
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)
  • 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 or disease Intervention/treatment Phase
Hepatitis B Drug: Peg IFN 2b Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : April 25, 2019
Estimated Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Peg IFN 2b
    Peg IFN 2b 1.5mcg/kg once every week for 48 weeks


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

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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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


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

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03123653     History of Changes
Other Study ID Numbers: ILBS-HBV-01
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
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