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Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00409019
First received: December 7, 2006
Last updated: May 6, 2008
Last verified: May 2008

December 7, 2006
May 6, 2008
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Complete list of historical versions of study NCT00409019 on ClinicalTrials.gov Archive Site
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Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy
A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study)

The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: Telbivudine
  • Drug: Adefovir
  • Drug: Tenofovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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Inclusion Criteria:

  • Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B
  • Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening.

Other 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 nucleoside(tide) therapy other than adefovir
  • Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months

Other exclusion criteria may apply.

Both
18 Years to 70 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00409019
CLDT600AUS05
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novartis, novatis
Novartis
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Novartis
May 2008

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