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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	July 11, 2005
Last Updated Date	February 27, 2009
Start Date ^†	July 2004
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00120835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
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
Brief Summary	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.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Chronic Hepatitis C
Intervention ^†	Drug: valopicitabine Drug: pegylated interferon
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†
Completion Date
Primary Completion Date
Eligibility 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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers
Contacts ^††
Location Countries ^†	United States, Puerto Rico
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00120835
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Idenix Pharmaceuticals
Collaborators ^††
Investigators ^†
Information Provided By	Idenix Pharmaceuticals
Verification Date	February 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.