SCH 503034 Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659)(COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	September 8, 2005
Last Updated Date	July 19, 2007
Start Date ^ICMJE	September 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00160251 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	SCH 503034 Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659)(COMPLETED)
Official Title ^ICMJE	PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C HCV-1 Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study
Brief Summary	The primary objective of this study is to determine the safe and effective dose range of SCH 503034 in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus SCH 503034.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Hepatitis C
Intervention ^ICMJE	Drug: SCH 503034
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 ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	April 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	Key inclusion criteria: Documented infection with chronic hepatitis C (CHC), genotype 1. Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin. No evidence of cirrhosis on liver biopsy. Results of physical examination and laboratory tests within specified ranges. Abstinence from use of abused substances. Key exclusion criteria: Women who are pregnant or nursing a child. Patients with cirrhosis, co-infection with Hepatitis B or HIV, and African-American patients (by a protocol amendment, African-American patients can enroll at Sites 1-32). Previous treatment with any HCV polymerase or protease inhibitor. Patients who relapsed following response to previous treatment. Evidence of advanced liver disease, or liver disease from a cause other than CHC. Pre-existing psychiatric condition.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00160251
Responsible Party
Study ID Numbers ^ICMJE	P03659
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	July 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP