Clinical trial NCT02939599: Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients
Official title: Long-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary hypertension (PH),
Increase blood pressure in the pulmonary artery
Increased blood pressure in the pulmonary vein
Increased blood pressure in the lung vasculature
Shortness of breath
Dizziness
Fainting
Leg swelling
Cough
Angina pector
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-10-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in adult patients with PAH. This study provides the patients who completed the QCC374X2201 study with the option to continue receiving QCC374. The study will monitor the long-term safety, tolerability and efficacy of QCC374 in patients with PAH.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Subject was enrolled in the QCC374X2201 study and completed per protocol

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) in Patients With PAH Over a Two Year Period
timeFrame: Two years
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 16 weeks
measure: Time to Reach the Maximum Plasma Concentration (Tmax)
timeFrame: 16 Weeks
measure: Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast)
timeFrame: 16 weeks
measure: Area Under the Plasma Concentration Time Curve From 0 to the End of a Dosing Interval (AUCtau)
timeFrame: 16 Weeks
measure: Change From Baseline in Six Minute Walk Distance (6MWD)
timeFrame: 16 weeks
measure: Change in Tricuspid Annular Peak Systolic Velocity (TA S') at Week 16 (Day 112) Using Echocardiography
timeFrame: Two Years
measure: Change From Baseline in RV Tei Index at Week 16 (Day 112) Using Echocardiography
timeFrame: 16 weeks
measure: Change From Baseline in RV Fractional Area Change at Week 16 (Day 112) Using Echocardiography
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
state: Cambridgeshire
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: