Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

NCT ID: NCT00131742

Last Updated: 2015-05-12

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

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-01-31

Brief Summary

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This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.

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

DOUBLE

Interventions

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telbivudine

Intervention Type DRUG

lamivudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented clinical history compatible with chronic hepatitis B infection

Exclusion Criteria

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
* Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog
Minimum Eligible Age

16 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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Beijing, , China

Site Status

Countries

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China

References

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Hou J, Yin YK, Xu D, Tan D, Niu J, Zhou X, Wang Y, Zhu L, He Y, Ren H, Wan M, Chen C, Wu S, Chen Y, Xu J, Wang Q, Wei L, Chao G, Constance BF, Harb G, Brown NA, Jia J. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial. Hepatology. 2008 Feb;47(2):447-54. doi: 10.1002/hep.22075.

Reference Type DERIVED
PMID: 18080339 (View on PubMed)

Other Identifiers

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NV-02B-015

Identifier Type: -

Identifier Source: org_study_id

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