Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00395421
First received: November 1, 2006
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Idenix Pharmaceuticals:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395421

Locations
United States, Georgia
Atlanta, Georgia, United States
United States, Virginia
Fairfax, Virginia, United States
Sponsors and Collaborators
Idenix Pharmaceuticals
Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

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
Study First Received: November 1, 2006
Last Updated: June 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Idenix Pharmaceuticals:
treatment-naive

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014