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

Further Study Details: 

Expected Total Enrollment:  175

Ages Eligible for Study:  18 Years   -   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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00118768

Kristin Kleber      617-995-9807    kleber.kristin@idenix.com

Arizona
      Phoenix,  Arizona,  United States; Recruiting
California
      San Diego,  California,  United States; Recruiting
      San Mateo,  California,  United States; Recruiting
Colorado
      Lakewood,  Colorado,  United States; Recruiting
Florida
      Bradenton,  Florida,  United States; Recruiting
Georgia
      Atlanta,  Georgia,  United States; Recruiting
Illinois
      Chicago,  Illinois,  United States; Recruiting
Maryland
      Laurel,  Maryland,  United States; Recruiting
Massachusetts
      Worcester,  Massachusetts,  United States; Recruiting
Michigan
      Detroit,  Michigan,  United States; Recruiting
Missouri
      Kansas City,  Missouri,  United States; Recruiting
New Mexico
      Alburquerque,  New Mexico,  United States; Recruiting
New York
      New York,  New York,  United States; Recruiting
Ohio
      Cincinnati,  Ohio,  United States; Recruiting
      Cleveland,  Ohio,  United States; Recruiting
Pennsylvania
      Philadelphia,  Pennsylvania,  United States; Recruiting
Tennessee
      Germantown,  Tennessee,  United States; Recruiting
Texas
      San Antonio,  Texas,  United States; Recruiting
Washington
      Tacoma,  Washington,  United States; Recruiting

Study ID Numbers:  NV-08A-006
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 11, 2005
ClinicalTrials.gov Identifier:  NCT00118768
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26