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

Primary Purpose

Chronic Hepatitis B

Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Tenofovir
Telbivudine
Tenofovir plus Telbivudine
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Hepatitis B, Tenofovir, Telbivudine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Tenofovir

Telbivudine

Tenofovir plus Telbivudine

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone

Secondary Outcome Measures

Percentage change in serum HBV DNA levels
Percentage of patients with ALT normalization
Percentage of patients with reduction in HBsAg concentration by >50%
Percentage of patients with virological breakthrough
Percentage of patients with primary treatment failure
Occurrence of adverse events

Full Information

First Posted
December 14, 2010
Last Updated
June 15, 2015
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01260610
Brief Title
Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients
Official Title
An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funds
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Hepatitis B, Tenofovir, Telbivudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tenofovir
Arm Type
Active Comparator
Arm Title
Telbivudine
Arm Type
Active Comparator
Arm Title
Tenofovir plus Telbivudine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tenofovir
Intervention Description
300 mg of Tenofovir daily
Intervention Type
Drug
Intervention Name(s)
Telbivudine
Intervention Description
600 mg of Telbivudine daily
Intervention Type
Drug
Intervention Name(s)
Tenofovir plus Telbivudine
Intervention Description
Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)
Primary Outcome Measure Information:
Title
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone
Time Frame
6 Months and 2 Years
Secondary Outcome Measure Information:
Title
Percentage change in serum HBV DNA levels
Time Frame
Baseline and 2 Years
Title
Percentage of patients with ALT normalization
Time Frame
Baseline and 2 Years
Title
Percentage of patients with reduction in HBsAg concentration by >50%
Time Frame
Baseline and 2 Years
Title
Percentage of patients with virological breakthrough
Time Frame
24 weeks
Title
Percentage of patients with primary treatment failure
Time Frame
12 weeks
Title
Occurrence of adverse events
Time Frame
2 Years

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr S. K. Sarin, MD, DM
Organizational Affiliation
Institute of Liver & Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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