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Open
Clinical Trial of New PI SCH 503034 Plus PegIntron in HCV Patients Nonresponsive
to Prior Treatment with Peginterferon Plus Ribavirin
This
study is currently recruiting patients.
Verified by Schering-Plough January 2006
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Sponsored by: |
Schering-Plough |
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Information provided by: |
Schering-Plough |
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ClinicalTrials.gov Identifier: |
NCT00160251 |
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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.
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Condition
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Intervention |
Phase |
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Chronic
Hepatitis C |
Drug: SCH
503034 |
Phase
II | MedlinePlus related topics: Hepatitis;
Hepatitis C
Study Type: Interventional
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 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 More Information Study
ID Numbers: P03659
Last Updated: January 18, 2006
Record first
received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00160251
Health Authority: United
States: Food and Drug Administration
ClinicalTrials.gov
processed this record on 2006-02-01 02/07/06 Source www.ClinicalTrials.gov | 
