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

This study has been completed.

First Received: June 30, 2005 Last Updated: February 27, 2009 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

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

U.S. FDA Resources

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

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

Show 19 Study Locations

Sponsors and Collaborators

Idenix Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	NV-08A-006
Study First Received:	June 30, 2005
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00118768 History of Changes
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
Anti-Infective Agents
Liver Diseases
Interferon Type I, Recombinant
Immunologic Factors
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human

Angiogenesis Inhibitors
Antiviral Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type I, Recombinant
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents
Growth Inhibitors

Interferon-alpha
RNA Virus Infections
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on September 09, 2009