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Phase 2 Study of VX-950, Pegasys, and Copegus in Hepatitis C- study sites
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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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