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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

117

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

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:

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

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Ribavirin
Tablet
Medicin: Telaprevir
Tablet
Andre navne:
  • VX-950
Medicin: Pegylated interferon alfa 2a
Solution for Injection
Eksperimentel: 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.
Medicin: Ribavirin
Tablet
Medicin: Telaprevir
Tablet
Andre navne:
  • VX-950
Medicin: Pegylated interferon alfa 2a
Solution for Injection
Eksperimentel: 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.
Medicin: Ribavirin
Tablet
Medicin: Telaprevir
Tablet
Andre navne:
  • VX-950
Medicin: Pegylated interferon alfa 2a
Solution for Injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Vertex Pharmaceuticals Incorporated

Samarbejdspartnere

Tibotec, Inc

Efterforskere

  • Studieleder: Nathalie Adda, MD, Vertex Pharmaceuticals Incorporated

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. oktober 2007

Primær færdiggørelse (Faktiske)

1. februar 2010

Studieafslutning (Faktiske)

1. februar 2010

Datoer for studieregistrering

Først indsendt

25. september 2007

Først indsendt, der opfyldte QC-kriterier

25. september 2007

Først opslået (Skøn)

26. september 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

  • VX06-950-107

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 .

Kliniske forsøg med Hepatitis C

Kliniske forsøg med Ribavirin

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