A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

NCT ID: NCT00057265

Last Updated: 2015-03-20

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

2003-02-28

Brief Summary

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This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.

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 or lamivudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV

Exclusion Criteria

* Patient is pregnant or breastfeeding
* Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2.
* Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time
* Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
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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Los Angeles, California, United States

Site Status

Orange, California, United States

Site Status

San Diego, California, United States

Site Status

Hackensack, New Jersey, United States

Site Status

Houston, Texas, United States

Site Status

Seoul, , South Korea

Site Status

Barcelona, , Spain

Site Status

Valencia, , Spain

Site Status

Bangkok, , Thailand

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

London, , United Kingdom

Site Status

Countries

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United States South Korea Spain Thailand Turkey (Türkiye) United Kingdom

References

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Zeuzem S, Gane E, Liaw YF, Lim SG, DiBisceglie A, Buti M, Chutaputti A, Rasenack J, Hou J, O'Brien C, Nguyen TT, Jia J, Poynard T, Belanger B, Bao W, Naoumov NV. Baseline characteristics and early on-treatment response predict the outcomes of 2 years of telbivudine treatment of chronic hepatitis B. J Hepatol. 2009 Jul;51(1):11-20. doi: 10.1016/j.jhep.2008.12.019. Epub 2009 Feb 12.

Reference Type DERIVED
PMID: 19345439 (View on PubMed)

Lai CL, Gane E, Liaw YF, Hsu CW, Thongsawat S, Wang Y, Chen Y, Heathcote EJ, Rasenack J, Bzowej N, Naoumov NV, Di Bisceglie AM, Zeuzem S, Moon YM, Goodman Z, Chao G, Constance BF, Brown NA; Globe Study Group. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med. 2007 Dec 20;357(25):2576-88. doi: 10.1056/NEJMoa066422.

Reference Type DERIVED
PMID: 18094378 (View on PubMed)

Other Identifiers

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NV-02B-007

Identifier Type: -

Identifier Source: org_study_id

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