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

NCT ID: NCT01260610

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tenofovir

Group Type ACTIVE_COMPARATOR

Tenofovir

Intervention Type DRUG

300 mg of Tenofovir daily

Telbivudine

Group Type ACTIVE_COMPARATOR

Telbivudine

Intervention Type DRUG

600 mg of Telbivudine daily

Tenofovir plus Telbivudine

Group Type EXPERIMENTAL

Tenofovir plus Telbivudine

Intervention Type DRUG

Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)

Interventions

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Tenofovir

300 mg of Tenofovir daily

Intervention Type DRUG

Telbivudine

600 mg of Telbivudine daily

Intervention Type DRUG

Tenofovir plus Telbivudine

Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr S. K. Sarin, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver & Biliary Sciences

Locations

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Institute of Liver & Biliary Sciences

New Delhi, , India

Site Status

Countries

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India

Other Identifiers

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CLDT600AIN05T

Identifier Type: -

Identifier Source: org_study_id

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