An Study of Efficacy and Safety of Clevudine

NCT01192854 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2013-05-14

No results posted yet for this study

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

Conditions

Interventions

DRUG

Clevudine

Clevudine flexible dosages of 30 mg/day

DRUG

Adefovir

Adefovir flexible dosages of 10 mg/day

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Guoping Yang · Xiangya Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01192854 on ClinicalTrials.gov