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Clinical Trials/NCT00128544
NCT00128544
Completed
Phase 2

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

Novartis0 sites130 target enrollmentMay 2005
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ConditionsHepatitis B
Drugstelbivudinevaltorcitabine

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Hepatitis B
Sponsor
Novartis
Enrollment
130
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
May 2007
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Novartis

Eligibility 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.

Outcomes

Primary Outcomes

Not specified

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