Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: NM283 plus Peg-IFNα-2a

• Registration Number: NCT00395421
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-01
• Study First Submitted QC: 2006-11-01
• Study First Posted: 2006-11-02
• Primary Completion: 2008-06
• Study Completion: 2008-08
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-09
• Last Update Posted: 2010-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	NM283 plus Peg-IFNα-2a	NM283(200 mg QD)plus Peg-IFNα-2a (180 µg QW)