A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C
A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of the Combination of Pegylated Interferon Alfa Plus NM283 (Valopicitabine) in Treatment-Naive Patients With Chronic Hepatitis C
1 other identifier
interventional
175
1 country
19
Brief Summary
This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
19 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
First Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 12, 2005
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedMarch 2, 2009
February 1, 2009
June 30, 2005
February 27, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease
- Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection)
You may not qualify if:
- Patient is pregnant or breastfeeding
- Patient is co-infected with HIV or Hepatitis B
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Mateo, California, United States
Unknown Facility
Lakewood, Colorado, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Laurel, Maryland, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Germantown, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Tacoma, Washington, United States
MeSH Terms
Conditions
Interventions
Condition 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
June 30, 2005
First Posted
July 12, 2005
Study Start
August 1, 2005
Last Updated
March 2, 2009
Record last verified: 2009-02