Back to resultsValopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
valopicitabine
pegylated interferon
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Genotype-1, Treatment-Naive
Eligibility Criteria
Inclusion Criteria: Documented clinical history compatible with genotype-1, chronic hepatitis C infection Treatment-naive (patient has received no previous therapy for hepatitis C viral infection) Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant 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
NCT00120835
Brief Title
Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (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 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.
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, Treatment-Naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, 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
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 genotype-1, chronic hepatitis C infection
Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Patient is pregnant
Patient is co-infected with hepatitis B or HIV
Other protocol-defined exclusion criteria may apply.
Facility Information:
City
Bradenton
State/Province
Florida
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Santurce
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
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