Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy
1 other identifier
interventional
N/A
1 country
11
Brief Summary
This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
11 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 11, 2005
CompletedFirst Posted
Study publicly available on registry
July 19, 2005
CompletedJune 10, 2010
June 1, 2010
July 11, 2005
June 9, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Documented clinical history compatible with chronic hepatitis C and compensated liver disease
- Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin
You may not qualify if:
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis B or HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 11, 2005
First Posted
July 19, 2005
Study Start
January 1, 2005
Last Updated
June 10, 2010
Record last verified: 2010-06