Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
An Open-Label, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and the Antiviral Activity of NM283 When Administered Alone and in Combination With Pegylated Interferon Alfa 2b to Treatment-Naive Adults With Genotype-1 Chronic Hepatitis C
1 other identifier
interventional
N/A
2 countries
3
Brief Summary
This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
3 active sites
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
July 1, 2004
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 genotype-1, chronic hepatitis C infection
- Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)
You may not qualify if:
- Patient is pregnant
- Patient is co-infected with hepatitis B or HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Santurce, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- 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
July 1, 2004
Last Updated
June 10, 2010
Record last verified: 2010-06