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NATAP: HCV Protease SCH 503034 Study

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  • claudine intexas
    NATAP http://natap.org/ _______________________________________________ Safety & Efficacy of Schering HCV Protease Inhibitor + Peg-Intron for Genotype 1
    Message 1 of 1 , Feb 20, 2006
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      NATAP http://natap.org/
      _______________________________________________
      Safety & Efficacy of Schering HCV Protease Inhibitor + Peg-Intron for Genotype 1 Non-responders to Peginterferon/ribavirin, with & without Ribavirin Phase II Study

      Â
      SCH 503034 HCV Protease Inhibitor Monotherapy in HCV Genotype 1 IFN Nonresponders (11/15/05)
      Â
      VX-950 Hep C Protease Inhibitor (11/15/05)
      Â
      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:Â 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:Â 300

      Study start:Â September 2005;Â Expected completion:Â 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  415-202-1506Â

            Investigational Site 19, San Diego, California, 92173, United States; Recruiting
      Public Contact  619-662-5400Â

      Illinois
            Investigational Site 17, Chicago, Illinois, 60611, United States; Recruiting
      Public Contact  312-503-0121Â

      Indiana
            Investigational Site 15, Indianapolis, Indiana, 46202, United States; Recruiting
      Public Contact  317-278-8118Â

      Maryland
            Investigational Site 12, Baltimore, Maryland, 21287, United States; Recruiting
      Public Contact  410-614-6089Â

      Massachusetts
            Investigational Site 13, Boston, Massachusetts, 02215, United States; Recruiting
      Public Contact  617-632-1070Â

      Missouri
            Investigational Site 6, St. Louis, Missouri, 63104, United States; Recruiting
      Public Contact  314-577-8764Â

            Investigational Site 20, Kansas City, Missouri, 64131, United States; Recruiting
      Public Contact  816-361-0055Â

      New York
            Investigational Site 14, New York, New York, 10021, United States; Recruiting
      Public Contact  212-746-4338Â

      North Carolina
            Investigational Site 3, Durham, North Carolina, 27710, United States; Recruiting
      Public Contact  919-668-7177Â

      Ohio
            Investigational Site 9, Cincinnati, Ohio, 45267-0595, United States; Recruiting
      Public Contact  513-584-2363Â

      Texas
            Investigational Site 23, Dallas, Texas, 75390, United States; Recruiting
      Public Contact  214-648-4801Â

      Virginia
            Investigational Site 18, Richmond, Virginia, 23298, United States; Recruiting
      Public Contact  804-828-4060Â

      France
            Investigational Site 29, Clichy, 92118, France; Recruiting
      Public Contact  01 40 87 50 95Â

            Investigational Site 30, Lyon, 69288, France; Recruiting
      Public Contact  04-72-41-39-31Â

            Investigational Site 31, Paris, 75651, France; Recruiting
      Public Contact  33-142-16-10-19Â

      Germany
            Investigational Site 26, HOMBURG / SAAR, 66421, Germany; Recruiting
      Public Contact  4968411623210Â

            Investigational Site 27, Hannover, 30623, Germany; Recruiting
      Public Contact  +49-511 532-2853Â

      Spain
            Investigational Site 32, Barcelona, 08035, Spain; Recruiting
      Public Contact  34932746000 ext 6561 _______________________________________________
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      _______________________________________________
      NATAP nataphcv mailing list -- nataphcv@...

      This is an annoucement-only mailing list. Do not reply.

      To unsubscribe: send a blank email to nataphcv-request@... with a subject of unsubscribe.


      For more information, see http://seven.pairlist.net/mailman/listinfo/nataphcv

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