A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00118768
First received: June 30, 2005
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).


Condition Intervention Phase
Chronic Hepatitis C
Drug: valopicitabine
Drug: Pegylated Interferon Alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of the Combination of Pegylated Interferon Alfa Plus NM283 (Valopicitabine) in Treatment-Naive Patients With Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Idenix Pharmaceuticals:

Estimated Enrollment: 175
Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease
  • Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection)
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with HIV or Hepatitis B
  • 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: NCT00118768

  Show 19 Study Locations
Sponsors and Collaborators
Idenix Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00118768     History of Changes
Other Study ID Numbers: NV-08A-006
Study First Received: June 30, 2005
Last Updated: February 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Idenix Pharmaceuticals:
Genotype-1, Chronic Hepatitis C

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
Interferon-alpha
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014