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Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B

This study has been completed.
Novartis Pharmaceuticals
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: August 8, 2005
Last updated: December 9, 2009
Last verified: December 2009

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 2

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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Estimated Enrollment: 130
Study Start Date: May 2005
Study Completion Date: May 2007

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

Inclusion Criteria:

  • Clinical history compatible with compensated chronic hepatitis B

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-hepatitis B virus (HBV) nucleoside or nucleotide at anytime.

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00128544

Hong Kong
Pokfulam, Hong Kong
New Zealand
Auckland, New Zealand
Singapore, Singapore
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided Identifier: NCT00128544     History of Changes
Other Study ID Numbers: NV-02C-004
Study First Received: August 8, 2005
Last Updated: December 9, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses processed this record on November 20, 2014