An extension study to evaluate the safety and tolerability of QCC374
Research type
Research Study
Full title
Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH
IRAS ID
218716
Contact name
Joanna Pepke-Zaba
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-001411-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
This is a Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with pulmonary arterial hypertension (PAH).
The compound to be investigated is a prostacyclin group of medicines that is currently being used for the treatment of PAH. The purpose of this study, as a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in adult patients with PAH, is to provide patients with the option to continue receiving QCC374 after completion of the QCC374X2201 trial, and monitor the long-term safety, tolerability and efficacy of QCC374 in patients with PAH.
The primary endpoint for this trial will be looking at how effective QCC374 can be on the reduction of the resistance of the pulmonary arteries.The Primary objective is to evaluate the safety and tolerability of QCC374 in patients with PAH over a two year period.
The study population will be comprised of male and female PAH patients who have completed the QCC374X2201 PoC study and wish to participate in the extension study. A total of approximately 38 subjects are planned to be enrolled and randomized in the QCC374X2201 study, with approximately 30 patients expected to complete the study.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0502
Date of REC Opinion
12 Jan 2018
REC opinion
Further Information Favourable Opinion