Back to resultsDose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
val-mCyd
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
Eligibility Criteria
Inclusion Criteria: Documented clinical history of chronic hepatitis C and compensated liver disease No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with HBV or HIV Other protocol-defined exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00227435
First Posted
September 26, 2005
Last Updated
April 25, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00227435
Brief Title
Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C
Official Title
A Phase I/II Double-Blind, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Val-mCyd (NM283) in Adults With Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
val-mCyd
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 chronic hepatitis C and compensated liver disease
No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Patient is pregnant or breastfeeding
Patient is co-infected with HBV or HIV
Other protocol-defined exclusion criteria may apply.
Facility Information:
City
Pasadena
State/Province
California
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C
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