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 |
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.
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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