Back to resultsStudy to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NM283 plus Peg-IFNα-2a
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring treatment-naive
Eligibility Criteria
Inclusion Criteria:
- Documented clinical history compatible with chronic hepatitis C and compensated liver disease
- Has not previously received anti-viral therapy for hepatitis C infection
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis B virus and/or HIV
Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
NM283(200 mg QD)plus Peg-IFNα-2a (180 µg QW)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00395421
First Posted
November 1, 2006
Last Updated
June 9, 2010
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00395421
Brief Title
Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin
Official Title
A Partially-blinded, Randomized, Parallel-group Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between Valopicitabine and Ribavirin When Administered in Combination With Pegylated Interferon Alfa-2a in Treatment-naive Patients With Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating 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
treatment-naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
NM283(200 mg QD)plus Peg-IFNα-2a (180 µg QW)
Intervention Type
Drug
Intervention Name(s)
NM283 plus Peg-IFNα-2a
Intervention Description
200 mg QD 180 µg QW
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
Has not previously received anti-viral therapy for hepatitis C infection
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis B virus and/or HIV
Other protocol-defined exclusion criteria may apply.
Facility Information:
City
Atlanta
State/Province
Georgia
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin
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