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

This study is ongoing, but not recruiting participants.

Sponsored by:	Idenix Pharmaceuticals
Information provided by:	Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00118768

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 II

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Interferon alfa-n1 Interferon alfa-2a Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Idenix Pharmaceuticals:

Estimated Enrollment:	175
Study Start Date:	July 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118768

Show 19 Study Locations

Sponsors and Collaborators

Idenix Pharmaceuticals

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	NV-08A-006
Study First Received:	June 30, 2005
Last Updated:	September 1, 2006
ClinicalTrials.gov Identifier:	NCT00118768
Health Authority:	United States: Food and Drug Administration

Keywords provided by Idenix Pharmaceuticals:

Genotype-1, Chronic Hepatitis C

Study placed in the following topic categories:

Interferon-alpha
Virus Diseases
Hepatitis
Interferon Type I, Recombinant
Liver Diseases
Digestive System Diseases

Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009