An Study of Efficacy and Safety of Clevudine
A Multi-center, Randomized, Double-blind, Positive-control, Phase III Trial of the Efficacy and Safety of Clevudine
1 other identifier
interventional
288
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 14, 2013
July 1, 2011
1.2 years
August 30, 2010
May 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.
48 weeks
Histological response
48 weeks
Secondary Outcomes (2)
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 Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may not qualify if:
- Subjects coinfected with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus
- Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration.
- Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease.
- Poorly controlled type I or type 2 diabetes mellitus
- Donation or loss more than 400 ml blood within 60 days of baseline.
- Known serious allergies to nucleoside/nucleotide analogs.
- Subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (1)
Xiangya hospital
Changsha, Hunan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guoping Yang
Xiangya Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2010
First Posted
September 1, 2010
Study Start
February 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 14, 2013
Record last verified: 2011-07