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

Information source: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Telaprevir (Drug); Ribavirin (Drug); Pegylated Interferon Alfa 2a (Drug); Placebo (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Vertex Pharmaceuticals Incorporated

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Vertex Pharmaceuticals Incorporated

Summary

Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Clinical Details

Official title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys), With Ribavirin (Copegus) in Subjects With Genotype 1 Hepatitis C Who Have Not Received Prior Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

Secondary outcome:

Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing

Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Subjects With Viral Relapse

Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA

- Have been infected with hepatitis C virus for greater than (>) 6 months

- Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2

- 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 Pegylated Interferon Alfa 2a or Ribavirin 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 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)

Locations and Contacts

Fundacion de Investigacion de Diego, Santurce 00909, Puerto Rico

Call For Information, Phoenix, Arizona, United States

Cedars-Sinai Medical Center, Los Angeles, California, United States

Stanford University Liver Research, Palo Alto, California, United States

Call For Information, San Francisco, California, United States

University of Colorado Hospital, Denver, Colorado, United States

South Denver Gastroenterology, Englewood, Colorado, United States

Shands Hospital University of Florida, Gainesville, Florida 32610, United States

Call for Information, Miami, Florida, United States

University of Chicago Medical Center, Chicago, Illinois, United States

Clarian Hospital, Indianapolis, Indiana 46202, United States

Gulf Coast Research Associates, Baton Rouge, Louisiana, United States

Call For Information, Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Call for Information, Boston, Massachusetts, United States

Call For Information, Worcester, Massachusetts, United States

Henry Ford Health System, Detroit, Michigan, United States

Call For Information, Rochester, Minnesota, United States

Saint Louis University, St. Louis, Missouri, United States

University of New Mexico, Albuquerque, New Mexico, United States

Call For Information, Manhasset, New York, United States

Call for Information, New York, New York, United States

Columbia University Medical Center, New York, New York, United States

Call For Information, Chapel Hill, North Carolina, United States

Call For Information, Durham, North Carolina, United States

University of Cincinnati College of Medicine, Cincinnati, Ohio, United States

Fox Chase/ Temple Cancer Center, Philadelphia, Pennsylvania 19140, United States

University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States

Baylor University Medical Center, Dallas, Texas, United States

Methodist Hospital of Dallas, Dallas, Texas, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States

Alamo Medical Research, San Antonio, Texas 78215, United States

Inova Fairfax Hospital, Annandale, Virginia 22003, United States

University of Virginia Health System, Charlotteville, Virginia, United States

Metropolitan Research, Fairfax, Virginia 22031, United States

McGuire VA Medical Center, Richmond, Virginia 23249, United States

Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin, United States

Additional Information

Starting date: June 2006
Last updated: June 25, 2014

Page last updated: August 23, 2015

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