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A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

9. juli 2014 oppdatert av: Vertex Pharmaceuticals Incorporated

A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

117

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
        • University of Calgary Medical Clinic
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Toronto, Ontario, Canada
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater
    • California
      • Los Angeles, California, Forente stater
      • San Diego, California, Forente stater
        • Kaiser Permanente Internal Medicine
      • San Francisco, California, Forente stater
    • Colorado
      • Denver, Colorado, Forente stater
        • University of Colorado Health Sciences Center
      • Englewood, Colorado, Forente stater
        • South Denver Gastroenterology
    • Florida
      • 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
        • University of Miami Center for Liver Diseases
      • Sarasota, Florida, Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago, Illinois, Forente stater
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, Forente stater
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater
        • Digestive and Liver Disease Clinic
    • 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 Israel Deaconess Medical Center
      • Worcester, Massachusetts, Forente stater
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, Forente stater
        • Henry Ford Hospital
    • Missouri
      • St Louis, Missouri, Forente stater
        • St Louis University
    • Nebraska
      • Omaha, Nebraska, Forente stater
        • The Nebraska Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forente stater
        • University of New Mexico
    • New York
      • Manhasset, New York, Forente stater
        • North Shore University Hospital
      • New York, New York, Forente stater
    • North Carolina
      • Durham, North Carolina, Forente stater
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Forente stater
        • University of Cincinnati
      • Cleveland, Ohio, Forente stater
    • Pennsylvania
      • Hershey, Pennsylvania, Forente stater
        • Penn State Hershey Medical Center
      • Pittsburgh, Pennsylvania, Forente stater
        • University of Pittsburgh Medical Center
    • 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
      • San Antonio, Texas, Forente stater
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, Forente stater
      • Charlottesville, Virginia, Forente stater
        • University of Virginia Health Systems
      • Fairfax, Virginia, Forente stater
        • Metropolitan Research
      • Richmond, Virginia, Forente stater
        • McGuire DVAMC
  • Frankrike
      • Creteil, Frankrike
        • Hospital Henri Mondor
      • Lyon, Frankrike
      • Nice, Frankrike
      • Paris, Frankrike
      • Pessac, Frankrike
      • Vandoeuvre, Frankrike
  • Nederland
      • Amsterdam, Nederland
        • Academic Medical Center
      • Leiden, Nederland
        • Leiden University Medical Center
      • Rotterdam, Nederland
        • Erasmus MC Medical Center
  • Puerto Rico
      • Santurce, Puerto Rico
        • Fundacion de Investigation de Diego
  • Storbritannia
      • London, Storbritannia
  • Tyskland
      • Berlin, Tyskland
      • Bonn, Tyskland
        • Universitatsklinikum Bonn
      • Cologne, Tyskland
        • University of Cologne
      • Dusseldorf, Tyskland, 40225
        • Uniklinik Duesseldorf
      • Frankfurt, Tyskland
      • Hannover, Tyskland
  • Østerrike
      • Vienna, Østerrike

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:

  • Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Telaprevir 750 mg 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
Legemiddel: Telaprevir
Tablett
Andre navn:
  • VX-950
Legemiddel: Pegylated interferon alfa 2a
Solution for Injection
Eksperimentell: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Telaprevir 750 mg tablet thrice daily for 12 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
Legemiddel: Telaprevir
Tablett
Andre navn:
  • VX-950
Legemiddel: Pegylated interferon alfa 2a
Solution for Injection
Eksperimentell: Other
Subjects received telaprevir 750 mg tablet thrice daily 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Legemiddel: Ribavirin
Tablett
Legemiddel: Telaprevir
Tablett
Andre navn:
  • VX-950
Legemiddel: Pegylated interferon alfa 2a
Solution for Injection

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
Tidsramme: 24 weeks after the completion of treatment (up to Week 72)
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).
24 weeks after the completion of treatment (up to Week 72)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline through Week 48
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 through Week 48

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Prior Relapsers With Undetectable HCV RNA
Tidsramme: 24 weeks after the completion of treatment (up to Week 72)
Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study 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).
24 weeks after the completion of treatment (up to Week 72)
Percentage of Subjects With End of Treatment Response
Tidsramme: End of treatment (up to Week 48)
Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. 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).
End of treatment (up to Week 48)
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
Tidsramme: 48 weeks after completion of treatment (up to Week 96)
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).
48 weeks after completion of treatment (up to Week 96)
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
Tidsramme: Baseline up to Week 72
Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.
Baseline up to Week 72

Samarbeidspartnere og etterforskere

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

Sponsor

Vertex Pharmaceuticals Incorporated

Samarbeidspartnere

Tibotec, Inc

Etterforskere

  • Studieleder: Nathalie Adda, MD, Vertex Pharmaceuticals Incorporated

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. oktober 2007

Primær fullføring (Faktiske)

1. februar 2010

Studiet fullført (Faktiske)

1. februar 2010

Datoer for studieregistrering

Først innsendt

25. september 2007

Først innsendt som oppfylte QC-kriteriene

25. september 2007

Først lagt ut (Anslag)

26. september 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

  • VX06-950-107

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. .

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