A Study Evaluating 24-Week Telaprevir-Based Treatment, or Extended Treatment to 48 Weeks, in Chronic Hepatitis C Patients Who Achieve a Rapid Viral Response

Condition(s) targeted: Hepatitis C

Intervention: telaprevir (Drug); ribavirin (Drug); peginterferon alfa-2a (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Vertex Pharmaceuticals Incorporated

Overall contact:
Central Contact Center, Phone: 877-634-VRTX, Email: medicalinfo@vrtx.com

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

Official title: A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response (eRVR) While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: To demonstrate the efficacy of telaprevir in combination with Pegasys® and Copegus® in treatment naive subjects with genotype 1 chronic hepatitis C.

Secondary outcome: To evaluate the safety of telaprevir in combination with Pegasys® and Copegus® in treatment naive subjects with genotype 1 chronic hepatitis C.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Has not received any previous treatment with any approved or investigational drug or

drug regimen for the treatment of hepatitis C

- Male and female subjects, 18 to 70 years of age, inclusive

- Genotype 1, chronic hepatitis C with detectable HCV RNA.

- Screening laboratory values, tests, and physical exam within acceptable ranges

- Able and willing to follow contraception requirements

- Able to read and understand, and willing to sign the informed consent form and abide

by the study restrictions.

Exclusion Criteria:

- Subject has any contraindications to Pegasys® or Copegus® therapy

- Evidence of hepatic decompensation in cirrhotic subjects

- History of organ transplant

- History of, or any current medical condition which could impact the safety of the

subject in participation in the study

Central Contact Center, Phone: 877-634-VRTX, Email: medicalinfo@vrtx.com

Brussels B1200, Belgium; Not yet recruiting

Liège 4000, Belgium; Not yet recruiting

Brussels B1070, Belgium; Not yet recruiting

Gent 9000, Belgium; Not yet recruiting

Amsterdam 1100 DE, Netherlands; Not yet recruiting

Arnhem 6815 AD, Netherlands; Not yet recruiting

Amsterdam 1081 HV, Netherlands; Not yet recruiting

Santurce 00909, Puerto Rico; Not yet recruiting

Birmingham, Alabama 35209, United States; Not yet recruiting

Birmingham, Alabama 35233, United States; Not yet recruiting

Phoenix, Arizona 85054, United States; Not yet recruiting

San Francisco, California 94115, United States; Not yet recruiting

san Diego, California 92115, United States; Not yet recruiting

Los Angeles, California 90048, United States; Not yet recruiting

Sacramento, California 95817, United States; Not yet recruiting

Fresno, California 93721, United States; Not yet recruiting

San Francisco, California 94143, United States; Not yet recruiting

La Jolla, California 92037, United States; Not yet recruiting

San Diego, California 92123, United States; Not yet recruiting

Aurora, Colorado 80045, United States; Not yet recruiting

Farmington, Connecticut 06030, United States; Not yet recruiting

Washington, District of Columbia 20010, United States; Not yet recruiting

Wellington, Florida 33414, United States; Not yet recruiting

Orlando, Florida 32803, United States; Not yet recruiting

Jacksonville, Florida 32224, United States; Not yet recruiting

Sarasota, Florida 34243, United States; Recruiting

Miami, Florida 33136, United States; Not yet recruiting

Gainsville, Florida 32610, United States; Not yet recruiting

Atlanta, Georgia 30309, United States; Recruiting

Marietta, Georgia 30060, United States; Recruiting

Atlanta, Georgia 30308, United States; Not yet recruiting

Honolulu, Hawaii 96817, United States; Not yet recruiting

Chicago, Illinois 60612, United States; Not yet recruiting

Chicago, Illinois 60611, United States; Not yet recruiting

Downers Grove, Illinois 60515, United States; Recruiting

Indianapolis, Indiana 46202, United States; Not yet recruiting

New Orleans, Louisiana 70112, United States; Not yet recruiting

Baltimore, Maryland 21287, United States; Not yet recruiting

Baltimore, Maryland 21201, United States; Not yet recruiting

Hyattsville, Maryland 20783, United States; Not yet recruiting

Laurel, Maryland 20707, United States; Not yet recruiting

Boston, Massachusetts 02215, United States; Not yet recruiting

Boston, Massachusetts 02111, United States; Not yet recruiting

Worcester, Massachusetts 01655, United States; Not yet recruiting

Boston, Massachusetts 02114, United States; Not yet recruiting

Novi, Michigan 48377, United States; Not yet recruiting

Detroit, Michigan 48202, United States; Not yet recruiting

Rochester, Minnesota 55905, United States; Not yet recruiting

St. Louis, Missouri 63110, United States; Not yet recruiting

St. Louis, Missouri 63104, United States; Not yet recruiting

Kansas City, Missouri 64131, United States; Not yet recruiting

Lebanon, New Hampshire 03756, United States; Not yet recruiting

Egg Harbor Township, New Jersey 08234, United States; Recruiting

Atlantic City, New Jersey 08401, United States; Not yet recruiting

Albuquerque, New Mexico 87131, United States; Not yet recruiting

New York, New York 10029, United States; Not yet recruiting

New York, New York 10021, United States; Not yet recruiting

Bronx, New York 10467, United States; Not yet recruiting

New York, New York 10032, United States; Not yet recruiting

Bayside, New York 11358, United States; Not yet recruiting

Manhasset, New York 11030, United States; Not yet recruiting

New York, New York 10016, United States; Recruiting

Chapel Hill, North Carolina 27514, United States; Not yet recruiting

Statesville, North Carolina 28687, United States; Not yet recruiting

Durham, North Carolina 27710, United States; Not yet recruiting

Cincinnati, Ohio 45267, United States; Not yet recruiting

Cleveland, Ohio 44109, United States; Not yet recruiting

Cincinnati, Ohio 45219, United States; Not yet recruiting

Portland, Oregon 97239, United States; Not yet recruiting

Philadelphia, Pennsylvania 19141, United States; Not yet recruiting

Providence, Rhode Island 02905, United States; Recruiting

Columbia, South Carolina 29204, United States; Not yet recruiting

Germantown, Tennessee 38138, United States; Recruiting

Dallas, Texas 75246, United States; Not yet recruiting

Dallas, Texas 75203, United States; Not yet recruiting

San Antonio, Texas 78215, United States; Not yet recruiting

Salt Lake City, Utah 84132, United States; Not yet recruiting

Annandale, Virginia 22003, United States; Not yet recruiting

Tacoma, Washington 98405, United States; Not yet recruiting

Seattle, Washington 98104, United States; Not yet recruiting

Milwaukee, Wisconsin 53226, United States; Not yet recruiting

Madison, Wisconsin 53792, United States; Not yet recruiting

Starting date: September 2008
Ending date: May 2010
Last updated: October 8, 2008