ong-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients
- Conditions
- Pulmonary arterial hypertensionMedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-001411-20-GB
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
• Written informed consent must be obtained before any assessment is performed.
• Subject was enrolled in the QCC374X2201 study and completed per protocol
Other protocol-defined inclusion criteria may apply.
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 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
• Subjects who have started receiving prostacyclin (epoprostenol), prostacyclin analogs (i.e. trepostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e. selexipag) since the last study drug intake in the QCC374X2201 study.
• Females who are pregnant, or who plan to become pregnant during the study, or who are breastfeeding
• Any known factor or disease that may interfere with treatment compliance or study conduct (i.e. drug or alcohol dependence)
• Subjects who withdrew consent from the study QCC374X2201
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of QCC374 in patients with PAH over a two year period;Secondary Objective: • To assess the treatment effect of QCC374 in PAH patients not previously dosed with QCC374 (Arm 2: those subjects previously in the placebo group of QCC374X2201)<br>• To evaluate the pharmacokinetics of QCC374 and its metabolite QCM441 in PAH patients not previously dosed with QCC374 (Arm 2: subjects previously in the placebo group of QCC374X2201);Primary end point(s): Adverse Events, Serious Adverse Events and all safety assessments;Timepoint(s) of evaluation of this end point: 2 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Six Minute Walk Distance (6MWD)<br>• Key RV function endpoints with echocardiography will include but not limited to tricuspid annular peak systolic velocity (TA S'), RV Tei index and RV fractional area change.<br>• PK parameters (Cmax, AUClast, AUCtau, Ctrough) of QCC374 and QCM441 in plasma;Timepoint(s) of evaluation of this end point: 16 weeks- 2 years