Back to resultsValopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
valopicitabine
pegylated interferon
ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Genotype-1, Previously failed treatment
Eligibility Criteria
Inclusion Criteria: Documented clinical history compatible with chronic hepatitis C and compensated liver disease Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis B or HIV Other protocol-defined exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00120861
Brief Title
Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 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 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.
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, Previously failed treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valopicitabine
Intervention Type
Drug
Intervention Name(s)
pegylated interferon
Intervention Type
Drug
Intervention Name(s)
ribavirin
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 compatible with chronic hepatitis C and compensated liver disease
Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis B or HIV
Other protocol-defined exclusion criteria may apply.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
New York
State/Province
New York
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
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