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

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ClinicalTrials.gov Identifier: NCT00128544
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : June 16, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B Drug: telbivudine Drug: valtorcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Telbivudine
U.S. FDA Resources





Information from the National Library of Medicine

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128544


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00128544     History of Changes
Other Study ID Numbers: NV-02C-004
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Hepatitis
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
Telbivudine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action