Clinical trial NCT00420784: A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: Genotype 1
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
timeFrame: 24 weeks after the completion of study drug dosing (up to Week 72)
Secondary outcomes:
measure: Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
timeFrame: Completion of study drug dosing (up to Week 48)
measure: Percentage of Subjects With Undetectable Plasma HCV RNA
timeFrame: Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
measure: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 2 weeks after last dose of study drug (up to Week 50)
measure: Number of Subjects With Viral Relapse
timeFrame: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
measure: Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
timeFrame: Week 2, 4, 8, 12, 16, 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Gastroenterology Associates
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: USC
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Hepatology Research
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Bardenton
country: United States
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
state: Florida
city: Sarasota
country: United States
facility: University Hepatitis Center at Bach & Godofsky
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Baton Rouge
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Portland
country: United States
facility: Virology Treatment Center, Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Beth Isreal Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: St Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
facility: University Internal Medicine Associates, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Gastroenterology Associates, PA
state: South Carolina
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Dallas
country: United States
facility: Liver Institute at Methodist Dallas
state: Texas
city: Houston
country: United States
facility: Advanced Liver Therapies
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Annandale
country: United States
state: Virginia
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Calgary
country: Canada
facility: University of Calgary Medical Clinic - Health Science Centre
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
facility: BC Hepatitis Program
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Berlin
country: Germany
facility: Universitatsmedizin Berlin
city: Frankfurt
country: Germany
facility: University Clinic Frankfurt, Department of Internal Medicine
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC University Medical Center
city: Santurce
country: Puerto Rico
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Li S, Zhu J, Zhang W, Chen Y, Zhang K, Popescu LM, Ma X, Lau WB, Rong R, Yu X, Wang B, Li Y, Xiao C, Zhang M, Wang S, Yu L, Chen AF, Yang X, Cai J. Signature microRNA expression profile of essential hypertension and its novel link to human cytomegalovirus infection. Circulation. 2011 Jul 12;124(2):175-84. doi: 10.1161/CIRCULATIONAHA.110.012237. Epub 2011 Jun 20.
citation: McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303. doi: 10.1056/NEJMoa0908014.