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Rollover Study of VX-770 in Cystic Fibrosis Subjects

12. juni 2015 opdateret af: Vertex Pharmaceuticals Incorporated

An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects With Cystic Fibrosis

The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This open-label, rollover study of orally administered VX-770 was conducted in participants with CF to evaluate the safety and efficacy of long-term VX-770 treatment. Participants who were previously enrolled in Study 102 (VX08-770-102/NCT00909532) and Study 103 (VX08-770-103/NCT00909727), and met certain criteria were eligible to enroll in this study (Study 105/VX08-770-105/NCT01117012).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

192

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Westmead, New South Wales, Australien
    • Queensland
      • Chermside, Queensland, Australien
      • Herston, Queensland, Australien
      • South Brisbane, Queensland, Australien
    • Victoria
      • Parkville, Victoria, Australien
    • Western Australia
      • Nedlands, Western Australia, Australien
      • Subiaco, Western Australia, Australien
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
    • Northern Ireland
      • Belfast, Northern Ireland, Det Forenede Kongerige
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
    • California
      • Oakland, California, Forenede Stater
      • Palo Alto, California, Forenede Stater
      • San Diego, California, Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater
    • Idaho
      • Boise, Idaho, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
    • Iowa
      • Iowa City, Iowa, Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
      • Detroit, Michigan, Forenede Stater
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater
    • Missouri
      • Kansas City, Missouri, Forenede Stater
      • St. Louis, Missouri, Forenede Stater
    • Nebraska
      • Omaha, Nebraska, Forenede Stater
    • New Jersey
      • Long Branch, New Jersey, Forenede Stater
    • New York
      • Buffalo, New York, Forenede Stater
      • New Hyde Park, New York, Forenede Stater
      • Syracuse, New York, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
      • Cleveland, Ohio, Forenede Stater
      • Columbus, Ohio, Forenede Stater
      • Toledo, Ohio, Forenede Stater
    • Oregon
      • Portland, Oregon, Forenede Stater
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater
      • Philadelphia, Pennsylvania, Forenede Stater
      • Pittsburgh, Pennsylvania, Forenede Stater
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater
      • Nashville, Tennessee, Forenede Stater
    • Utah
      • Salt Lake City, Utah, Forenede Stater
    • Virginia
      • Chrlottesville, Virginia, Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater
  • Frankrig
      • Paris, Frankrig
      • Roscoff, Frankrig
  • Irland
      • Cork, Irland
      • Dublin, Irland
  • Tjekkiet
      • Prague, Tjekkiet
  • Tyskland
      • Erlangen, Tyskland
      • Jena, Tyskland
      • Munich, Tyskland
      • Wurzburg, Tyskland

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

6 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Participants who have completed the assigned study treatment in Study 102 or Study 103
  2. Participants who are females of childbearing potential must have a negative urine pregnancy test on Day 1 (first dose of VX-770)
  3. Participants who are able to understand and comply with protocol requirements, restrictions, and instructions and likely to complete the study as planned, as judged by the investigator
  4. Participants of child bearing potential and who are sexually active must meet the contraception requirements
  5. Participants must sign the informed consent form (ICF), and where appropriate, assent must be obtained

Exclusion Criteria:

  1. Participants with a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
  2. Participants with a history of study treatment intolerance as observed in their previous VX-770 study that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject
  3. Participants who are pregnant, planning a pregnancy, breast-feeding, or not willing to follow contraception requirements
  4. Participants taking any inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4), including certain herbal medications (for example, St. John's Wort) and grapefruit/grapefruit juice

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: VX-770
VX-770 (ivacaftor) 150 milligram (mg) tablet orally twice daily (q12h).
Medicin: Ivacaftor
Andre navne:
  • VX-770

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Study 105: Day 1 up to Week 168
Adverse Event: any untoward medical occurrence in a participant during the study, including any unfavorable and unintended sign, symptom, or disease whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that increased in severity or frequency after obtaining informed consent and assent (where applicable). SAE: medical event or condition, which resulted in any of following, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Non-Serious AEs included all AEs except SAEs.
Study 105: Day 1 up to Week 168

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Annualized Rate of Decline From Study 105 Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 96
Tidsramme: Study 105: Baseline through Week 96
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as Study 105 Day 15.
Study 105: Baseline through Week 96
Absolute Change From Study 105 Baseline in Percent Predicted FEV1 Through Week 96
Tidsramme: Study 105: Baseline through Week 96
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in Study 105. Absolute Change at Week 48 and Week 96 are reported.
Study 105: Baseline through Week 96
Absolute Change From Study 105 Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 96
Tidsramme: Study 105: Baseline through Week 96
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Absolute Change at Week 48 and Week 96 are reported.
Study 105: Baseline through Week 96
Annualized Pulmonary Exacerbation Event Rate
Tidsramme: Study 105: Day 1 through Week 96
Annualized event rate was calculated by regression with negative binomial distribution.
Study 105: Day 1 through Week 96
Annualized Duration of Pulmonary Exacerbation Events
Tidsramme: Study 105: Day 1 through Week 96
Study 105: Day 1 through Week 96
Absolute Change From Study 105 Baseline in Weight Through Week 96
Tidsramme: Study 105: Baseline through Week 96
Weight is a measurement of nutritional status. Absolute change in weight, measured in kilograms (kg), at Week 48 and Week 96 are reported.
Study 105: Baseline through Week 96

Samarbejdspartnere og efterforskere

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

Sponsor

Vertex Pharmaceuticals Incorporated

Samarbejdspartnere

Cystic Fibrosis Foundation

Efterforskere

  • Ledende efterforsker: Edward McKone, MD, St. Vincent's University Hospital

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. juli 2010

Primær færdiggørelse (Faktiske)

1. maj 2014

Studieafslutning (Faktiske)

1. maj 2014

Datoer for studieregistrering

Først indsendt

3. maj 2010

Først indsendt, der opfyldte QC-kriterier

3. maj 2010

Først opslået (Skøn)

5. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VX08-770-105
  • PERSIST

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 Cystisk fibrose

Kliniske forsøg med Ivacaftor

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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