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Clinical Trials/NCT00227435
NCT00227435
Completed
Phase 1

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

Merck Sharp & Dohme LLC0 sitesFebruary 2003

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic Hepatitis C
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2003
End Date
July 2004
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Not specified

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