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Safety & Efficacy of Schering HCV Protease Inhibitor + Peg-Intron for Genotype 1 Non-responders to Peginterferon/ribavirin, with & without Ribavirin Phase II Study
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SCH 503034 HCV Protease Inhibitor Monotherapy in HCV Genotype 1 IFN Nonresponders (11/15/05)
VX-950 Hep C Protease Inhibitor (11/15/05)
Combination therapy with SCH-503034 HCV Protease Inhibitor & PegIntron in Non-Responders: phase !b study results (11/15/05)
"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 (Study P03659)"
This study is currently recruiting patients.
Verified by Schering-Plough January 2006
Sponsored by:
Schering-Plough
Information provided by:
Schering-Plough
Purpose
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.
Phase II
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Further study details as provided by Schering-Plough:
Expected Total Enrollment: 300
Study start: September 2005; Expected completion: April 2007
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00160251
California
Investigational Site 10, San Francisco, California, 94115, United States; Recruiting
Public Contact 415-202-1506
Investigational Site 19, San Diego, California, 92173, United States; Recruiting
Public Contact 619-662-5400
Illinois
Investigational Site 17, Chicago, Illinois, 60611, United States; Recruiting
Public Contact 312-503-0121
Indiana
Investigational Site 15, Indianapolis, Indiana, 46202, United States; Recruiting
Public Contact 317-278-8118
Maryland
Investigational Site 12, Baltimore, Maryland, 21287, United States; Recruiting
Public Contact 410-614-6089
Massachusetts
Investigational Site 13, Boston, Massachusetts, 02215, United States; Recruiting
Public Contact 617-632-1070
Missouri
Investigational Site 6, St. Louis, Missouri, 63104, United States; Recruiting
Public Contact 314-577-8764
Investigational Site 20, Kansas City, Missouri, 64131, United States; Recruiting
Public Contact 816-361-0055
New York
Investigational Site 14, New York, New York, 10021, United States; Recruiting
Public Contact 212-746-4338
North Carolina
Investigational Site 3, Durham, North Carolina, 27710, United States; Recruiting
Public Contact 919-668-7177
Ohio
Investigational Site 9, Cincinnati, Ohio, 45267-0595, United States; Recruiting
Public Contact 513-584-2363
Texas
Investigational Site 23, Dallas, Texas, 75390, United States; Recruiting
Public Contact 214-648-4801
Virginia
Investigational Site 18, Richmond, Virginia, 23298, United States; Recruiting
Public Contact 804-828-4060
France
Investigational Site 29, Clichy, 92118, France; Recruiting
Public Contact 01 40 87 50 95
Investigational Site 30, Lyon, 69288, France; Recruiting
Public Contact 04-72-41-39-31
Investigational Site 31, Paris, 75651, France; Recruiting
Public Contact 33-142-16-10-19
Germany
Investigational Site 26, HOMBURG / SAAR, 66421, Germany; Recruiting
Public Contact 4968411623210
Investigational Site 27, Hannover, 30623, Germany; Recruiting
Public Contact +49-511 532-2853
Spain
Investigational Site 32, Barcelona, 08035, Spain; Recruiting
Public Contact 34932746000 ext 6561
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