Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: NM283 plus Peg-IFNα-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395421

NV-08A-008

Details and patient eligibility

About

This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis C infection.

Enrollment: 114 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented clinical history compatible with chronic hepatitis C and compensated liver disease
• Has not previously received anti-viral therapy for hepatitis C infection

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Patient is pregnant or breastfeeding
• Patient is co-infected with hepatitis B virus and/or HIV

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 1 patient group

A

Experimental group

Description:

NM283(200 mg QD)plus Peg-IFNα-2a (180 µg QW)

Treatment:

Drug: NM283 plus Peg-IFNα-2a