Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:February 2003
End Date:July 2004

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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

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.


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.
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