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Clinical Trials/NCT01192854
NCT01192854
Completed
Phase 3

A Multi-center, Randomized, Double-blind, Positive-control, Phase III Trial of the Efficacy and Safety of Clevudine

Eisai Co., Ltd.1 site in 1 country288 target enrollmentFebruary 2010
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ConditionsChronic Hepatitis B
InterventionsClevudineAdefovir
DrugsClevudineAdefovir

Overview

Phase
Phase 3
Intervention
Clevudine
Conditions
Chronic Hepatitis B
Sponsor
Eisai Co., Ltd.
Enrollment
288
Locations
1
Primary Endpoint
Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
May 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Intervention: Clevudine

2

Intervention: Adefovir

Outcomes

Primary Outcomes

Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.

Time Frame: 48 weeks

Histological response

Time Frame: 48 weeks

Secondary Outcomes

  • Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay.(48 weeks)
  • Percent of patients with normalization of alanine aminotransferase (ALT) at week 48(48 weeks)

Study Sites (1)

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