Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B

NCT ID: NCT00128544

Last Updated: 2017-06-16

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-05-31

Brief Summary

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This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.

Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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telbivudine

Intervention Type DRUG

valtorcitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical history compatible with compensated chronic hepatitis B

Exclusion Criteria

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C virus, hepatitis D virus or HIV
* Patient has previously received lamivudine, adefovir dipivoxil or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide at anytime.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Locations

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Pokfulam, , Hong Kong

Site Status

Auckland, , New Zealand

Site Status

Singapore, , Singapore

Site Status

Countries

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Hong Kong New Zealand Singapore

Other Identifiers

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NV-02C-004

Identifier Type: -

Identifier Source: org_study_id

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