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A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

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

Condition(s) targeted: Hepatitis C

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

Phase: Phase 3

Status: Completed

Sponsored by: Vertex Pharmaceuticals Incorporated

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

Summary

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Clinical Details

Official title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C

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: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment

Secondary outcome:

Number of Subjects With Undetectable HCV RNA at Week 72

Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment

Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12

Number of Subjects With Undetectable HCV RNA at Week 12

Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)

Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment

Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment

Number of Subjects With Viral Relapse Planned and Viral Relapse Actual

Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels

Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis

Fatigue Severity Scale (FSS) Total Score

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

Eligibility

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 Hepatitis C Virus (HCV) Ribonucleic

Acid (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

Locations and Contacts

Buenos Aires, Argentina

Darlinghurst, Australia

Fitzroy, Australia

Greenslopes, Australia

Melbourne, Australia

Perth, Australia

Westmead, Australia

Woolloongabba, Australia

Linz, Austria

Vienna, Austria

Calgary, Canada

Toronto, Canada

Vancouver, Canada

Winnipeg, Canada

Clichy, France

Creteil, France

Grenoble, France

Lyon, France

Nice, France

Paris, France

Pessac, France

Toulouse, France

Berlin, Germany

Bochum, Germany

Dusseldorf, Germany

Frankfurt, Germany

Freiburg, Germany

Hamburg, Germany

Hannover, Germany

Koln, Germany

Muenchen, Germany

Haifa, Israel

Jerusalem, Israel

Nazareth, Israel

Petah Tikva, Israel

Tel Hashomer, Israel

Bologna, Italy

Milano, Italy

Torino, Italy

Bialystok, Poland

Czeladz, Poland

Kielce, Poland

Krakow, Poland

Lodz, Poland

Wroclaw, Poland

Santurce 00909, Puerto Rico

Barcelona, Spain

Valencia, Spain

Glasgow, United Kingdom

Hampstead, United Kingdom

London, United Kingdom

Birmingham, Alabama 35209, United States

Birmingham, Alabama 35294, United States

Phoenix, Arizona 85054, United States

Fresno, California 93721, United States

LaJolla, California 92037, United States

Long Beach, California 90822, United States

Los Angeles, California 90033, United States

Los Angeles, California 90048, United States

San Diego, California 92123, United States

San Diego, California 92154, United States

San Diego, California 92103, United States

San Francisco, California 94115, United States

San Francisco, California 94121, United States

San Francisco, California 94143, United States

Aurora, Colorado 80045, United States

Gainesville, Florida 32610, United States

Jacksonville, Florida 32224, United States

Jacksonville, Florida 32256, United States

Miami, Florida 33136, United States

Orlando, Florida 32803, United States

Sarasota, Florida 34243, United States

South Miami, Florida 33143, United States

Atlanta, Georgia 30308, United States

Savannah, Georgia 31405, United States

Honolulu, Hawaii 96817, United States

Chicago, Illinois 60637, United States

Carmel, Indiana 46032, United States

Indianapolis, Indiana 46202, United States

Portland, Maine 04102, United States

Baltimore, Maryland 21287, United States

Laurel, Maryland 20707, United States

Boston, Massachusetts 02114, United States

Boston, Massachusetts 02215, United States

Worcester, Massachusetts 01655, United States

Detroit, Michigan 48202, United States

Kansas City, Missouri 64131, United States

St Louis, Missouri 63104, United States

Omaha, Nebraska 68105, United States

Albuquerque, New Mexico 87131, United States

Manhasset, New York 11030, United States

New York City, New York 10003, United States

New York City, New York 10021, United States

New York City, New York 10029, United States

New York City, New York 10032, United States

Valhalla, New York 10595, United States

Chapel Hill, North Carolina 27599, United States

Charlotte, North Carolina 28203, United States

Durham, North Carolina 27710, United States

Fayetteville, North Carolina 28304, United States

Cincinatti, Ohio 45267, United States

Cincinnati, Ohio 45219, United States

Cleveland, Ohio 44195, United States

Hershey, Pennsylvania 17033, United States

Philadelphia, Pennsylvania 19104, United States

Pittsburgh, Pennsylvania 15213, United States

Columbia, South Carolina 29204, United States

Germantown, Tennessee 38138, United States

Dallas, Texas 75390, United States

Dallas, Texas 75203, United States

Dallas, Texas 75246, United States

Houston, Texas 77030, United States

San Antonio, Texas 78215, United States

Annandale, Virginia 22003, United States

Charlottesville, Virginia 22908, United States

Richmond, Virginia 23249, United States

Additional Information

Starting date: March 2008
Last updated: July 16, 2014

Page last updated: August 23, 2015

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