Long-term safety and efficacy of ivacaftor in patients with cystic fibrosis who have the Gly551Asp-CFTR mutation: a phase 3, open-label extension study (PERSIST)
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F14%3A10293132" target="_blank" >RIV/00064203:_____/14:10293132 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11130/14:10293132
Result on the web
<a href="http://dx.doi.org/10.1016/S2213-2600(14)70218-8" target="_blank" >http://dx.doi.org/10.1016/S2213-2600(14)70218-8</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/S2213-2600(14)70218-8" target="_blank" >10.1016/S2213-2600(14)70218-8</a>
Alternative languages
Result language
angličtina
Original language name
Long-term safety and efficacy of ivacaftor in patients with cystic fibrosis who have the Gly551Asp-CFTR mutation: a phase 3, open-label extension study (PERSIST)
Original language description
Background Ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, is approved for the treatment of patients with cystic fibrosis aged 6 years or older with Gly551Asp-CFTR. We assessed the safety and efficacy of ivacaftor during 96 weeks of PERSIST in patients with cystic fibrosis who completed a previous 48-week, placebo-controlled trial of the drug (STRIVE or ENVISION). Methods In this phase 3, open-label extension study, patients received ivacaftor 150 mg every 12 h in addition to their prescribed cystic fibrosis therapies. Patients who received placebo in their previous study initiated ivacaftor in this extension study. Patients were eligible if they had a Gly551Asp-CFTR mutation on at least one allele. The primary objective was to assess the long-term safety profile of ivacaftor as assessed by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, and physical examination; secondary measures included change in forced expirato
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FC - Pneumology
OECD FORD branch
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Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2014
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
The Lancet Respiratory Medicine
ISSN
2213-2600
e-ISSN
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Volume of the periodical
2
Issue of the periodical within the volume
11
Country of publishing house
GB - UNITED KINGDOM
Number of pages
9
Pages from-to
902-910
UT code for WoS article
000344909400016
EID of the result in the Scopus database
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