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

Rollover Study of VX-770 in Cystic Fibrosis Subjects

12. juni 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

192

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

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

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

6 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: VX-770
VX-770 (ivacaftor) 150 milligram (mg) tablet orally twice daily (q12h).
Legemiddel: Ivacaftor
Andre navn:
  • VX-770

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Vertex Pharmaceuticals Incorporated

Samarbeidspartnere

Cystic Fibrosis Foundation

Etterforskere

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

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. juli 2010

Primær fullføring (Faktiske)

1. mai 2014

Studiet fullført (Faktiske)

1. mai 2014

Datoer for studieregistrering

Først innsendt

3. mai 2010

Først innsendt som oppfylte QC-kriteriene

3. mai 2010

Først lagt ut (Anslag)

5. mai 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. juli 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2015

Sist bekreftet

1. juni 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VX08-770-105
  • PERSIST

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 Cystisk fibrose

Kliniske studier på Ivacaftor

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Gabon

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere