Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients

June 15, 2015 updated by: Institute of Liver and Biliary Sciences, India

An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients

Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.

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Withdrawn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
      • New Delhi, India
        • Institute of Liver & 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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HBeAg negative at screening
  • Documented chronic Hepatitis B
  • Treatment naive
  • Compensated liver disease

Exclusion Criteria:

  • Chronic Hepatitis B with Child Pugh B & C
  • HBeAg positive
  • Decompensated liver disease

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tenofovir
Drug: Tenofovir
300 mg of Tenofovir daily
Active Comparator: Telbivudine
Drug: Telbivudine
600 mg of Telbivudine daily
Experimental: Tenofovir plus Telbivudine
Drug: Tenofovir plus Telbivudine
Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone
Time Frame: 6 Months and 2 Years
6 Months and 2 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change in serum HBV DNA levels
Time Frame: Baseline and 2 Years
Baseline and 2 Years
Percentage of patients with ALT normalization
Time Frame: Baseline and 2 Years
Baseline and 2 Years
Percentage of patients with reduction in HBsAg concentration by >50%
Time Frame: Baseline and 2 Years
Baseline and 2 Years
Percentage of patients with virological breakthrough
Time Frame: 24 weeks
24 weeks
Percentage of patients with primary treatment failure
Time Frame: 12 weeks
12 weeks
Occurrence of adverse events
Time Frame: 2 Years
2 Years

Collaborators and Investigators

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

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Dr S. K. Sarin, MD, DM, Institute of Liver & Biliary Sciences

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

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDT600AIN05T

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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