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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:
Novartis Identifier:
First received: August 8, 2005
Last updated: May 8, 2015
Last verified: May 2015
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
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 Novartis:

Estimated Enrollment: 130
Study Start Date: May 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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.

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Please refer to this study by its identifier: NCT00128544

Hong Kong
Pokfulam, Hong Kong
New Zealand
Auckland, New Zealand
Singapore, Singapore
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Additional Information: Identifier: NCT00128544     History of Changes
Other Study ID Numbers: NV-02C-004
Study First Received: August 8, 2005
Last Updated: May 8, 2015

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
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
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017