'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT

February 7, 2018 updated by: Institute of Liver and Biliary Sciences, India

To Study the Efficacy of 'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT - A Randomized Control Trial

After fulfillment of the selection criteria, all the patients included in the trial will be administered Tenofovir that will be continued for 3 months and then stopped for 1 month, LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir and thereafter at 4 months patients with ALT >/= 1.5 times ULN will be randomised in 2 groups to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone which will be continued for 48 weeks and the patients with no rise in ALT will be excluded. Patients will be closely monitored during the period of stopping tenofovir post pulse therapy and liver function tests will be performed weekly. Patients will be closely observed for the development of acute hepatitis or decompensation during the 4 - week period of drug withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be tested every 3 months. After stopping treatment followup will be done at 24 weeks post stoppage of treatment to look for sustained seroconversion and virological/biochemical response

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Treatment naive chronic HBV infection i.e detectable HBsAg for past 6 months,
  2. HBeAg (+),
  3. ALT < ULN (Upper Limit Normal) on 2 or more occasions in last 6 months [ULN: 45]
  4. HBV DNA >2000 IU/mL
  5. Age > 18 years

Exclusion Criteria:

  1. Decompensated Cirrhosis
  2. Severe HBV flare with reactivation
  3. Presentation as ACLF (Acute on Chronic liver Failure)
  4. Baseline ALT > ULN (Upper Limit Normal)
  5. Contraindications to PEG-IFN therapy
  6. Prior HBV antiviral therapy within 6 months of enrollment
  7. Co-infections with HCV/HIV
  8. ANA +(autoantibodies suggestive of autoimmune disease) >1:80
  9. Patient not willing for enrollment in the study
  10. Pregnancy, lactation
  11. Patients who leave the study/ discontinue the therapy before completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tenofovir + Interferon alpha 2 b
Drug: Tenofovir disoproxil Fumarate
Active Comparator: Tenofovir
Drug: Tenofovir + Interferon alpha 2b

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained [ 6 months after stopping treatment] HBeAg seroconversion to anti-Hbe on two consecutive assays, at least 1 month apart
Time Frame: 65 weeks
65 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HBsAg loss
Time Frame: 64 weeks
64 weeks
Absence of quantifiable serum HBV DNA
Time Frame: 64 weeks
64 weeks
Development of serious adverse effects, acute hepatitis or hepatic decompensation
Time Frame: 64 weeks
64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-HBV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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