drugset

drugset / Trial / NCT01614457

Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)

NCT01614457 ↗

Phase 3 Completed 70 enrolled Vertex Pharmaceuticals Incorporated Cystic Fibrosis Foundation · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CFTR mutation.

Timeline

Start: 2012-07
Primary completion: 2013-10
Completion: 2013-10

Outcome

Missed primary endpoint

registry p = 0.1979; Least squares (LS) Mean Difference 2.1114 (95% CI -1.1305 to 5.3532) NCT01614457 ↗

paper Although this study did not show a significant improvement in % predicted FEV1 PMID 26070913 ↗

release “While we are disappointed that the study in people with the R117H mutation did not meet its primary endpoint” vrtx.com ↗

Publications

Moss RB, Flume PA, Elborn JS, Cooke J, Rowe SM, McColley SA, Rubenstein RC, Higgins M; VX11-770-110 (KONDUCT) Study Group. Efficacy and safety of ivacaftor in patients with cystic fibrosis who have an Arg117His-CFTR mutation: a double-blind, randomised controlled trial. Lancet Respir Med. 2015 Jul;3(7):524-33. doi: 10.1016/S2213-2600(15)00201-5. Epub 2015 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivacaftor	Other / unclassified	150 mg	Oral

Indications