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Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

This study has been withdrawn prior to enrollment.
(Study cancelled: Withdrawn before enrollment of any participants)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00409019
First received: December 7, 2006
Last updated: March 5, 2015
Last verified: March 2015

December 7, 2006
March 5, 2015
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March 2011   (final data collection date for primary outcome measure)
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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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: Telbivudine
    Study cancelled: Withdrawn before enrollment of any participants
  • Drug: Adefovir
  • Drug: Tenofovir
  • Experimental: 1
    Study cancelled: Withdrawn before enrollment of any participants
    Intervention: Drug: Telbivudine
  • Experimental: 2
    Study cancelled: Withdrawn before enrollment of any participants
    Intervention: Drug: Adefovir
  • Experimental: 3
    Study cancelled: Withdrawn before enrollment of any participants
    Intervention: 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
0
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March 2011   (final data collection date for primary outcome measure)

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   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
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United States
 
NCT00409019
CLDT600AUS05
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Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2015

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