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New Hep C Protease Inhibitor
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Phase 1 clinical results will be presented by investigators at this year's AASLD meeting in San Francisco.
These Phase 1 studies investigate SCH 503034 from Schering Plough both as monotherapy and in combination with PEG-Intron in genotype 1 patients who were nonresponders to peginterferon + ribavirin combination therapy. It is important to note that these Phase 1 studies were conducted with a capsule formulation that is viable for larger-scale clinical studies and, potentially, for commercial development.
Schering-Plough will be initiating a dose-finding study with our SCH 503034 capsule designed to address certain questions that need answered before they can move to a larger, more fully-integrated clinical development program.
Official Study 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
Dose Finding Study
"Safety and Efficacy of 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"
This study is not yet open for patient recruitment.
Verified by Schering-Plough September 2005
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.
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Expected Total Enrollment: 300
Study start: September 2005
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
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.
* 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.
Please refer to this study by ClinicalTrials.gov identifier NCT00160251
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