Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Long-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02939599
• Other study ID #: CQCC374X2201E1
• Status: Terminated
• Phase: Phase 2
• Start date: February 1, 2018
• Est. completion date: November 6, 2018

Study information

• Verified date: February 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• QCC374
0.015mg and 0.06mg

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Heidelberg
United Kingdom	Novartis Investigative Site	Cambridge	Cambridgeshire
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) in Patients With PAH Over a Two Year Period	Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported	Two years
Secondary	Maximum Observed Plasma Concentration (Cmax)	Cmax is the maximum (peak) observed plasma drug concentration after single dose administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed	16 weeks
Secondary	Time to Reach the Maximum Plasma Concentration (Tmax)	Tmax is the time to reach maximum plasma concentration after single dose administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.	16 Weeks
Secondary	Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast)	AUClast is the area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.	16 weeks
Secondary	Area Under the Plasma Concentration Time Curve From 0 to the End of a Dosing Interval (AUCtau)	AUCtau is the area under the plasma concentration-time curve from time zero to the end of the dosing interval. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed	16 Weeks
Secondary	Change From Baseline in Six Minute Walk Distance (6MWD)	The Six Minute Walk Test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. Only descriptive analysis performed.	16 weeks
Secondary	Change in Tricuspid Annular Peak Systolic Velocity (TA S') at Week 16 (Day 112) Using Echocardiography	Key Right Ventricular (RV) function endpoints such as Tricuspid Annular Peak Systolic Velocity (TA S') were assessed with echocardiography. Only descriptive analysis performed.	Two Years
Secondary	Change From Baseline in RV Tei Index at Week 16 (Day 112) Using Echocardiography	Key Right Ventricular (RV) function endpoints such as Tei Index were assessed with echocardiography. The RV Tei index is using both systolic and diastolic time intervals to evaluate the overall global dysfunction of the right ventricle in PAH patients. A lower number in RV Tei Index indicates an improvement. Only descriptive analysis performed.	16 weeks
Secondary	Change From Baseline in RV Fractional Area Change at Week 16 (Day 112) Using Echocardiography	Key Right Ventricular (RV) function endpoints such as Tei Index were assessed with echocardiography. The RV Tei index is using both systolic and diastolic time intervals to evaluate the overall global dysfunction of the right ventricle in PAH patients. A lower number in RV Tei Index indicates an improvement. Only descriptive analysis performed.	16 weeks

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com