A single center, open-label, two-period, non-randomized, paired-design study to compare steady-state plasma levels following switch from a 10 mg/ml treprostinil formulation to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH)

AOP Orphan Pharmaceuticals GmbH0 个研究点目标入组 16 人开始时间: 2021年9月6日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•- Signed informed consent form
•- Male or Female, aged 18 years at screening or above
•- Patient is treated with 10 mg/ml treprostinil since at least two weeks on stable dose with no dose escalation planned for at least two more weeks
•- Patient is on stable dose of at least 15 ng/kg/min since at least 2 weeks with an even number as programmed flow rate
•- Patient is diagnosed with PAH (Group 1)
•- Patient is in stable health condition
•- Any concomitant medication has been maintained on stable dose since at least 72 hours
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 16
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Patients receiving any other strength of treprostinil
•- Patients diagnosed with any other form of PH (e.g. CTEPH)
•- Patient with signs of disease progression or worsening requiring up-titration of dose
•- Patient shows signs of acute infusion site infection
•- Patient reports infusion site pain scale > 3 (5-scale intensity score) at time of screening
•- Patient has a history of serious adverse drug reactions possibly related to treprostinil
•- Patient was diagnosed with severe hepatic or renal impairments or any other disease possibly impacting PK of treprostinil
•- History of non-compliance
•- Currently smoking > 10 cigarettes per day
•- History of alcohol or drug abuse
•- Pregnant or lactating women

发起方