Science and Research

A Phase IIb, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Subjects with Cystic Fibrosis Aged 18 Years or Older (HIT-CF-CHOICES)

The primary objective of the study is to evaluate the efficacy of DIR/POS/NES after 8 weeks compared to placebo in (a) CF patients with rare CFTR mutations and a high organoid response to DIR/POS/NES and (b) CF patients with rare CFTR mutations not pre-selected on organoid response.

Study details
Study-ID: NCT06468527, 2022-500410-26-01
Study-ID: NCT06468527, 2022-500410-26-01
DZL Disease Area: CFBE
DZL Disease Area: CFBE
Study Type: Interventional
Study Type: Interventional
DZL Role: DZL recruiting center
DZL Role: DZL recruiting center
Funding: Externally - public
Funding: Externally - public
DZL Participating Sites: BIH / Charité - Associated Partner, BREATH
DZL Participating Sites: BIH / Charité - Associated Partner, BREATH
Start Date: 12.07.2024
Completion Date: 01.06.2025
Status: Closed
Status: Closed
DZL recruiting center
Link to Study


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