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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014