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Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00132652
First received: August 18, 2005
Last updated: May 8, 2015
Last verified: May 2015

August 18, 2005
May 8, 2015
February 2005
December 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00132652 on ClinicalTrials.gov Archive Site
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Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B
This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.
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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: Lamivudine
  • Drug: Telbivudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented clinical history compatible with chronic hepatitis B
  • Patient has compensated liver disease
  • Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with hepatitis C, hepatitis D or HIV
  • Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months

Other protocol-defined exclusion criteria may apply.

Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   China,   France,   Israel,   New Zealand,   Singapore,   Taiwan,   Thailand,   United Kingdom
 
NCT00132652
NV-02B-019
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Novartis
Novartis Pharmaceuticals
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Novartis
May 2015

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