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Fw: NATAP: VX-950+Pegasys+Copegus Study Sites

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  • Alley Pat
    NATAP http://natap.org/ ... Phase 2 Study of VX-950, Pegasys, and Copegus in Hepatitis C- study sites This study is currently recruiting patients. Verified by
    Message 1 of 1 , Jun 30, 2006
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      NATAP http://natap.org/
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      Phase 2 Study of VX-950, Pegasys, and Copegus in Hepatitis C- study sites

      This study is currently recruiting patients.
      Verified by Vertex Pharmaceuticals Incorporated June 2006
      Sponsored by: Vertex Pharmaceuticals Incorporated
      Information provided by: Vertex Pharmaceuticals Incorporated

      Purpose
      Study the effectiveness of VX-950 in combination with Peg-Interferon alpha and Ribavirin in reducing plasma HCV RNA levels

      Primary Outcomes: Plasma HCV RNA 24 weeks post-treatment
      Secondary Outcomes: Plasma HCV RNA at other time points; Safety assessment; Analysis of viral variants; VX-950, Peg-IFN-a-2a, and RBV pharmacokinetics

      Expected Total Enrollment: 260

      Study start: June 2006

      Eligibility
      Ages Eligible for Study: 18 Years - 65 Years,
      Genders Eligible for Study: Both

      Criteria

      Inclusion Criteria:

      * Hepatitis C virus Genotype 1 with detectable plasma HCV RNA
      * Have been infected with Hepatitis C virus for >6 months.
      * Seronegative for HbsAg and HIV1 and HIV2
      * Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
      * Female subjects must have a negative pregnancy test at all visits before the first dose.

      Exclusion Criteria:

      * Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
      * Any medical contraindications to Peg-IFN-a-2a or RBV therapy
      * Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis (NASH) or primary biliary cirrhosis.
      * Diagnosed or suspected hepatocellular carcinoma.
      * Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before Study start
      * Alcohol abuse or excessive use in the last 12 months.
      * Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).

      Location and Contact Information
      Please refer to this study by ClinicalTrials.gov identifier NCT00336479

      Call Center 617-444-6777

      Colorado
      South Denver Gastroenterology, Englewood, Colorado, United States; Recruiting
      Marcello Kugelmas, MD, Principal Investigator

      Florida
      Shands Hospital University of Florida, Gainesville, Florida, 32610, United States; Recruiting
      David R. Nelson, M.D., Principal Investigator

      Call for Information, Miami, Florida, United States; Recruiting
      Call For Information, Principal Investigator

      Louisiana
      Gulf Coast Research Associates, Baton Rouge, Louisiana, United States; Recruiting
      Shaban Faruqui, MD, Principal Investigator

      New Mexico
      University of New Mexico, Albuquerque, New Mexico, United States; Recruiting
      Sanjeev Arora, MD, Principal Investigator

      New York
      Call for Information, New York, New York, United States; Recruiting
      Call For Information, Principal Investigator

      Texas
      Alamo Medical Research, San Antonio, Texas, 78215, United States; Recruiting
      Eric J. Lawitz, M.D., Principal Investigator

      Methodist Hospital of Dallas, Dallas, Texas, United States; Recruiting
      Reem Ghalib, MD, Principal Investigator

      Virginia
      McGuire VA Medical Center, Richmond, Virginia, 23249, United States; Recruiting
      Mitchell Shiffman, M.D., Principal Investigator

      Metropolitan Research, Fairfax, Virginia, 22031, United States; Recruiting
      Vinod K. Rustgi, M.D., Principal Investigator

      Inova Fairfax Hospital, Annandale, Virginia, 22003, United States; Recruiting
      Zobair M. Younossi, M.D., MPH, Principal Investigator

      Puerto Rico
      Fundacion de Investigacion de Diego, Santurce, 00909, Puerto Rico; Recruiting
      Maribel Rodriguez-Torres, M.D., Principal Investigator

      Study chairs or principal investigators

      Medical Monitor, Study Director, Vertex Pharmaceuticals Incorporated





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