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

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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)

This study has been completed.
Information provided by Schering-Plough

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Descriptive Information Fields
Brief Title ^†	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 ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Chronic Hepatitis C
Intervention ^†	Drug: SCH 503034
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	300
Start Date ^†	September 2005
Completion Date	April 2007
Eligibility Criteria ^†	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 ^††
Location Countries ^†

Administrative Information Fields
NCT ID ^†	NCT00160251
Organization ID	P03659
Secondary IDs ^††
Study Sponsor ^†	Schering-Plough
Collaborators ^††
Investigators ^†
Information Provided By	Schering-Plough
Verification Date	July 2007
First Received Date ^†	September 8, 2005
Last Updated Date	July 19, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.