Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients
Status:
Terminated
Trial end date:
2018-06-07
Target enrollment:
Participant gender:
Summary
This was a non-confirmatory, randomized, placebo controlled, subject and investigator blinded
study of QCC374 in PAH subjects. The study was planned to have 2 Parts: Part 1, an initial
safety cohort with a 0.03 mg bid starting dose, and Part 2, a larger cohort with a 0.06 mg
bid starting dose. However, due to early study termination following Part 1, Part 2 was not
completed. Both study parts were comprised of four phases: a screening period for up to 28
days, a titration period of 2 weeks, a stable dose period of 14 weeks and safety follow-up
period for 28 days. At the end of the treatment period of 16 weeks, eligible patients were
given the option to participate in a separate long-term extension study (CQCC374X2201E1
(NCT02939599)), where all patients were treated with an individual optimal dose of QCC374.