Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

9. juli 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

465

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Ribavirin
tablett
Andre navn:
  • RBV
Legemiddel: Pegylert interferon Alfa 2a
Injeksjonsvæske, oppløsning
Andre navn:
  • Peg-IFN-alfa-2a
Legemiddel: Telaprevir
tablett
Andre navn:
  • VX-950
Eksperimentell: 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.
Legemiddel: Ribavirin
tablett
Andre navn:
  • RBV
Legemiddel: Pegylert interferon Alfa 2a
Injeksjonsvæske, oppløsning
Andre navn:
  • Peg-IFN-alfa-2a
Legemiddel: Telaprevir
tablett
Andre navn:
  • VX-950
Eksperimentell: 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.
Legemiddel: Pegylert interferon Alfa 2a
Injeksjonsvæske, oppløsning
Andre navn:
  • Peg-IFN-alfa-2a
Legemiddel: Telaprevir
tablett
Andre navn:
  • 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.
Legemiddel: Ribavirin
tablett
Andre navn:
  • RBV
Legemiddel: Pegylert interferon Alfa 2a
Injeksjonsvæske, oppløsning
Andre navn:
  • Peg-IFN-alfa-2a
Legemiddel: Matching Placebo
Tablet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentandel av forsøkspersoner med upåviselig plasmahepatitt C-virus (HCV) ribonukleinsyre (RNA) i uke 24 etter fullføring av studien medikamentdosering
Tidsramme: 24 uker etter fullføring av studiemedikamentdosering (opptil uke 72)
Plasma HCV RNA-nivået ble målt ved bruk av Roche TaqMan HCV RNA-analyse. Nedre deteksjonsgrense var 10 internasjonale enheter per milliliter (IE/ml).
24 uker etter fullføring av studiemedikamentdosering (opptil uke 72)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vertex Pharmaceuticals Incorporated

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2007

Primær fullføring (Faktiske)

1. desember 2008

Studiet fullført (Faktiske)

1. april 2009

Datoer for studieregistrering

Først innsendt

8. januar 2007

Først innsendt som oppfylte QC-kriteriene

8. januar 2007

Først lagt ut (Anslag)

11. januar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. august 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2014

Sist bekreftet

1. juli 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VX06-950-106

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Hepatitt C

Kliniske studier på Ribavirin

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Hungary

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere