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Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00395421
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : June 10, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: NM283 plus Peg-IFNα-2a Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
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
Study Start Date : October 2006
Primary Completion Date : June 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395421


Locations
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.
ClinicalTrials.gov Identifier: NCT00395421     History of Changes
Other Study ID Numbers: NV-08A-008
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by Merck Sharp & Dohme Corp.:
treatment-naive

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs