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

9. juli 2014 opdateret af: Vertex Pharmaceuticals Incorporated

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

465

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary Medical Clinic - Health Science Centre
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • BC Hepatitis Program
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Toronto, Ontario, Canada
      • Toronto, Ontario, Canada
        • Toronto Western Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
        • Birmingham Gastroenterology Associates
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Forenede Stater
        • USC
      • San Diego, California, Forenede Stater
        • University of California, San Diego
      • San Diego, California, Forenede Stater
        • Kaiser Permanente Hepatology Research
      • San Francisco, California, Forenede Stater
        • University of California San Francisco
    • Colorado
      • Denver, Colorado, Forenede Stater
        • University of Colorado Health Sciences Center
      • Englewood, Colorado, Forenede Stater
    • Florida
      • Bardenton, Florida, Forenede Stater
      • Gainesville, Florida, Forenede Stater
        • University of Florida
      • Jacksonville, Florida, Forenede Stater
        • Borland-Groover Clinic
      • Jacksonville, Florida, Forenede Stater
        • Mayo Clinic Jacksonville
      • Miami, Florida, Forenede Stater
      • Sarasota, Florida, Forenede Stater
        • University Hepatitis Center at Bach & Godofsky
    • Georgia
      • Atlanta, Georgia, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater
        • Gulf Coast Research, LLC
    • Maine
      • Portland, Maine, Forenede Stater
        • Virology Treatment Center, Maine Medical Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Beth Isreal Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, Forenede Stater
        • Henry Ford Hospital
    • Missouri
      • St Louis, Missouri, Forenede Stater
        • Saint Louis University
    • Nebraska
      • Omaha, Nebraska, Forenede Stater
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
    • New York
      • Manhasset, New York, Forenede Stater
        • North Shore University Hospital
      • New York, New York, Forenede Stater
    • North Carolina
      • Durham, North Carolina, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
        • University Internal Medicine Associates, Inc.
      • Cleveland, Ohio, Forenede Stater
        • Cleveland Clinic
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater
      • Pittsburgh, Pennsylvania, Forenede Stater
    • South Carolina
      • Columbia, South Carolina, Forenede Stater
        • Columbia Gastroenterology Associates, PA
    • Tennessee
      • Germantown, Tennessee, Forenede Stater
        • Memphis Gastroenterology Group
    • Texas
      • Dallas, Texas, Forenede Stater
        • Liver Institute at Methodist Dallas
      • Houston, Texas, Forenede Stater
        • Advanced Liver Therapies
      • San Antonio, Texas, Forenede Stater
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, Forenede Stater
      • Fairfax, Virginia, Forenede Stater
        • Metropolitan Research
      • Richmond, Virginia, Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater
  • Holland
      • Amsterdam, Holland
        • Academic Medical Center
      • Leiden, Holland
        • Leiden University Medical Center
      • Rotterdam, Holland
        • Erasmus MC University Medical Center
  • Puerto Rico
      • Santurce, Puerto Rico
  • Tyskland
      • Berlin, Tyskland
        • Universitätsmedizin Berlin
      • Frankfurt, Tyskland
        • University Clinic Frankfurt, Department of Internal Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
Medicin: Ribavirin
tablet
Andre navne:
  • RBV
Medicin: Pegyleret interferon Alfa 2a
Opløsning til injektion
Andre navne:
  • Peg-IFN-alfa-2a
Medicin: Telaprevir
tablet
Andre navne:
  • VX-950
Eksperimentel: Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Medicin: Ribavirin
tablet
Andre navne:
  • RBV
Medicin: Pegyleret interferon Alfa 2a
Opløsning til injektion
Andre navne:
  • Peg-IFN-alfa-2a
Medicin: Telaprevir
tablet
Andre navne:
  • VX-950
Eksperimentel: Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
Medicin: Pegyleret interferon Alfa 2a
Opløsning til injektion
Andre navne:
  • Peg-IFN-alfa-2a
Medicin: Telaprevir
tablet
Andre navne:
  • VX-950
Placebo komparator: PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Medicin: Ribavirin
tablet
Andre navne:
  • RBV
Medicin: Pegyleret interferon Alfa 2a
Opløsning til injektion
Andre navne:
  • Peg-IFN-alfa-2a
Medicin: Matching Placebo
Tablet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af forsøgspersoner med ikke-detekterbar plasmahepatitis C-virus (HCV) ribonukleinsyre (RNA) i uge 24 efter afslutningen af ​​studiets lægemiddeldosering
Tidsramme: 24 uger efter afslutningen af ​​studiets lægemiddeldosering (op til uge 72)
Plasma-HCV-RNA-niveauet blev målt under anvendelse af Roche TaqMan HCV-RNA-assay. Den nedre grænse for detektion var 10 internationale enheder pr. milliliter (IE/ml).
24 uger efter afslutningen af ​​studiets lægemiddeldosering (op til uge 72)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
Tidsramme: Completion of study drug dosing (up to Week 48)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Completion of study drug dosing (up to Week 48)
Percentage of Subjects With Undetectable Plasma HCV RNA
Tidsramme: 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)
Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group "PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week" and at 48 weeks after last dose of study drug for treatment groups "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week" were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
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)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to 2 weeks after last dose of study drug (up to Week 50)
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Baseline up to 2 weeks after last dose of study drug (up to Week 50)
Number of Subjects With Viral Relapse
Tidsramme: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Tidsramme: Week 2, 4, 8, 12, 16, 24
Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Week 2, 4, 8, 12, 16, 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vertex Pharmaceuticals Incorporated

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2007

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. april 2009

Datoer for studieregistrering

Først indsendt

8. januar 2007

Først indsendt, der opfyldte QC-kriterier

8. januar 2007

Først opslået (Skøn)

11. januar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VX06-950-106

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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