An Study of Efficacy and Safety of Clevudine

Phase 3

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Clevudine; Drug: Adefovir

• Registration Number: NCT01192854
• Lead Sponsor: Eisai Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-07
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Clevudine	-
2	Adefovir	-

Primary Outcome Measures

Name	Time	Method
Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.	48 weeks
Histological response	48 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xiangya hospital; 🇨🇳 Changsha, Hunan, China