DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

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

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

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys«), and Ribavirin (RBV, Copegus«) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

Clinical Details

Official title: A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys«), and Ribavirin (Copegus«) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy

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 Completion of Study Drug Dosing

Percentage of Subjects With Undetectable Plasma HCV RNA

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: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females between 18 and 70 years old

- Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or

equal to (>=) 10,000 international units per milliliter (IU/mL)

- Must have chronic hepatitis C (genotype 1) and have already received at least one

prior course of pegylated interferon alfa 2a with ribavirin

- Cannot also be infected with Human Immunodeficiency Virus or hepatitis B

- Must be judged to be in general good health and able to receive Pegasys® and Copegus®

- No drug or alcohol abuse in the last year

- Must agree to use two effective methods of birth control during the study and for 6

months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)

- If you are a woman, you cannot be in this study if you are pregnant or nursing

Exclusion Criteria:

- Participation in any clinical trial of a HCV protease inhibitor of any duration

- Prior response to therapy and failure to achieve SVR which was due to treatment

non-compliance

- 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

- History of or current evidence of decompensated liver disease

- Participation in any clinical trial of an investigational drug 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

Universitatsmedizin Berlin, Berlin, Germany

University Clinic Frankfurt, Department of Internal Medicine, Frankfurt, Germany

Academic Medical Center, Amsterdam, Netherlands

Leiden University Medical Center, Leiden, Netherlands

Erasmus MC University Medical Center, Rotterdam, Netherlands

Santurce, Puerto Rico

Birmingham Gastroenterology Associates, Birmingham, Alabama, United States

University of Calgary Medical Clinic - Health Science Centre, Calgary, Alberta T2N 4N1, Canada

Edmonton, Alberta, Canada

BC Hepatitis Program, Vancouver, British Columbia, Canada

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

USC, Los Angeles, California, United States

Kaiser Permanente Hepatology Research, San Diego, California, United States

University of California, San Diego, San Diego, California, United States

University of California San Francisco, San Francisco, California, United States

University of Colorado Health Sciences Center, Denver, Colorado, United States

Englewood, Colorado, United States

Bardenton, Florida, United States

University of Florida, Gainesville, Florida, United States

Borland-Groover Clinic, Jacksonville, Florida, United States

Mayo Clinic Jacksonville, Jacksonville, Florida, United States

Miami, Florida, United States

University Hepatitis Center at Bach & Godofsky, Sarasota, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

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

Virology Treatment Center, Maine Medical Center, Portland, Maine, United States

Winnipeg, Manitoba, Canada

Johns Hopkins University, Baltimore, Maryland, United States

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

Henry Ford Hospital, Detroit, Michigan, United States

Saint Louis University, St Louis, Missouri, United States

Omaha, Nebraska, United States

Albuquerque, New Mexico, United States

North Shore University Hospital, Manhasset, New York, United States

New York, New York, United States

Durham, North Carolina, United States

University Internal Medicine Associates, Inc., Cincinnati, Ohio, United States

Cleveland Clinic, Cleveland, Ohio, United States

Toronto, Ontario, Canada

Toronto Western Hospital, Toronto, Ontario, Canada

Hershey, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Columbia Gastroenterology Associates, PA, Columbia, South Carolina, United States

Memphis Gastroenterology Group, Germantown, Tennessee, United States

Liver Institute at Methodist Dallas, Dallas, Texas, United States

Advanced Liver Therapies, Houston, Texas, United States

Alamo Medical Research, San Antonio, Texas, United States

Annandale, Virginia, United States

Metropolitan Research, Fairfax, Virginia, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Additional Information

Starting date: February 2007
Last updated: July 9, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017