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An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B - Article


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General Topics A-Z

Lamivudine

3TC; Epivir; Epivir-HBV


Clinical Trial: An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B

This study is no longer recruiting patients.

Sponsored by: Idenix Pharmaceuticals
Information provided by: Idenix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00124241

Purpose

This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.
Condition Intervention Phase
Hepatitis B
  Drug: telbivudine
 Drug: lamivudine
 Phase II

MedlinePlus related topics:  Hepatitis B

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients with Chronic Hepatitis B Who Have Completed Study NV-02B-003

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug
  • Patient remains seropositive for hepatitis B surface antigen (HBsAg)

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breast-feeding
  • Patient has signs of decompensated chronic hepatitis B

Other protocol-defined exclusion criteria may apply.

Location Information


California
      Los Angeles,  California,  United States

Canada
      Toronto,  Canada

China
      Hong Kong,  China

France
      Paris,  France

More Information

http://www.idenix.com

Study ID Numbers:  NV-02B-010
Last Updated:  August 3, 2005
Record first received:  July 25, 2005
ClinicalTrials.gov Identifier:  NCT00124241
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23


Source: ClinicalTrials.gov
Cache Date: August 24, 2005

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Page Updated: June 1, 2005
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