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Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients with Chronic Hepatitis B - Article


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Vaccinations for Hepatitis A and B

Clinical Trial: Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients with Chronic Hepatitis B

This study is currently recruiting patients.
Verified by Idenix Pharmaceuticals August 2005

Sponsored by: Idenix Pharmaceuticals
Information provided by: Idenix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00128544

Purpose

This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.
Condition Intervention Phase
Hepatitis B
  Drug: telbivudine
 Drug: valtorcitabine
 Phase II

MedlinePlus related topics:  Hepatitis B

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Randomized, Blinded, Phase IIb Trial of Telbivudine (LdT) Versus the Combination of Telbivudine and Valtorcitabine (Val-LdC) in Patients with Chronic Hepatitis B

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with hepatitis C virus, hepatitis D virus or HIV
  • Patient has previously received lamivudine, adefovir dipivoxil or an investigational anti-HBV nucleoside or nucleotide at anytime.

Other protocol-defined inclusion criteria may apply.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00128544

Keith Pietropaolo      617-995-9818    pietropaolo.keith@idenix.com

Hong Kong
      Pokfulam,  Hong Kong; Recruiting

New Zealand
      Auckland,  New Zealand; Recruiting

Singapore
      Singapore,  Singapore; Recruiting

More Information

Study ID Numbers:  NV-02C-004
Last Updated:  August 9, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128544
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23


Source: ClinicalTrials.gov
Cache Date: August 24, 2005


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Page Updated: September 6, 2005
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