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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: val-mCyd

Study type: Interventional

Funder types: Industry

Identifiers

NCT00227435

NV-08A-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind