Back to resultsA Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
valopicitabine
Pegylated Interferon Alfa
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Genotype-1, Chronic Hepatitis C
Eligibility Criteria
Inclusion Criteria: 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) Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with HIV or Hepatitis B Other protocol-defined exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00118768
First Posted
June 30, 2005
Last Updated
February 27, 2009
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00118768
Brief Title
A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Genotype-1, Chronic Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valopicitabine
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon Alfa
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
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)
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Patient is pregnant or breastfeeding
Patient is co-infected with HIV or Hepatitis B
Other protocol-defined exclusion criteria may apply.
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Mateo
State/Province
California
Country
United States
City
Lakewood
State/Province
Colorado
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Laurel
State/Province
Maryland
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Alburquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C
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