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Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin

This study has been completed.
Novartis Pharmaceuticals
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: November 1, 2006
Last updated: June 9, 2010
Last verified: June 2010
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.

Condition Intervention Phase
Chronic Hepatitis C Drug: NM283 plus Peg-IFNα-2a Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Partially-blinded, Randomized, Parallel-group Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between Valopicitabine and Ribavirin When Administered in Combination With Pegylated Interferon Alfa-2a in Treatment-naive Patients With Chronic Hepatitis C

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 114
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
NM283(200 mg QD)plus Peg-IFNα-2a (180 µg QW)
Drug: NM283 plus Peg-IFNα-2a
200 mg QD 180 µg QW


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00395421

United States, Georgia
Atlanta, Georgia, United States
United States, Virginia
Fairfax, Virginia, United States
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: John Z. Sullivan-Bólyai, MD, MPH, Idenix Pharmaceuticals, Inc. Identifier: NCT00395421     History of Changes
Other Study ID Numbers: NV-08A-008
Study First Received: November 1, 2006
Last Updated: June 9, 2010

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 19, 2017