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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00124241
First received: July 25, 2005
Last updated: May 8, 2015
Last verified: May 2015
July 25, 2005
May 8, 2015
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February 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00124241 on ClinicalTrials.gov Archive Site
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An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatitis B
  • Drug: telbivudine
  • Drug: lamivudine
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2005
February 2003   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
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Contact information is only displayed when the study is recruiting subjects
Canada,   China,   France,   United States
 
 
NCT00124241
NV-02B-010
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Novartis
Novartis Pharmaceuticals
Not Provided
Novartis
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP