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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
 Drug: Telbivudine
Drug: Adefovir
Drug: Tenofovir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: novartis, novatis
ClinicalTrials.gov Identifier: NCT00409019     History of Changes
Other Study ID Numbers: CLDT600AUS05
Study First Received: December 7, 2006
Last Updated: May 6, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
 Adefovir
Adefovir dipivoxil
Tenofovir
Tenofovir disoproxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013