Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C

This study is ongoing, but not recruiting participants.

Sponsored by:	Idenix Pharmaceuticals
Information provided by:	Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00120835

Purpose

This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: valopicitabine Drug: pegylated interferon	Phase I Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and the Antiviral Activity of NM283 When Administered Alone and in Combination With Pegylated Interferon Alfa 2b to Treatment-Naive Adults With Genotype-1 Chronic Hepatitis C

Eligibility

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

Criteria

Inclusion Criteria:

Documented clinical history compatible with genotype-1, chronic hepatitis C infection
Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Patient is pregnant
Patient is co-infected with hepatitis B or HIV

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120835

Locations

United States, Florida

Bradenton, Florida, United States
United States, Texas

San Antonio, Texas, United States
Puerto Rico

Santurce, Puerto Rico

Sponsors and Collaborators

Idenix Pharmaceuticals

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	NV-08A-003
Study First Received:	July 11, 2005
Last Updated:	September 1, 2006
ClinicalTrials.gov Identifier:	NCT00120835
Health Authority:	United States: Food and Drug Administration

Keywords provided by Idenix Pharmaceuticals:

Genotype-1
Treatment-Naive

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Hepatitis
Virus Diseases

Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents

Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009