Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2016-001411-20-DE
• Date of registration: 07/08/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients
• Scientific title: Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH
• Date of first enrolment: 17/10/2017
• Target sample size: 38
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001411-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Korea, Republic of, Taiwan, United Kingdom, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion 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
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

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
Other protocol-defined exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Pulmonary arterial hypertension
MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Code: QCC374 0.015 mg
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: TBD
Current Sponsor code: QCC374
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.015-

Product Code: QCC374 0.06 mg
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: TBD
Current Sponsor code: QCC374
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.06-

Primary Outcome(s)

Primary end point(s): Adverse Events, Serious Adverse Events and all safety assessments

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)
• 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)

Timepoint(s) of evaluation of this end point: 2 years

Main Objective: To evaluate the safety and tolerability of QCC374 in patients with PAH over a two year period

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 16 weeks- 2 years

Secondary end point(s): • Six Minute Walk Distance (6MWD)
• 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.
• PK parameters (Cmax, AUClast, AUCtau, Ctrough) of QCC374 and QCM441 in plasma

Secondary ID(s)

2016-001411-20-GB

CQCC374X2201E1

NCT02939599

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 20/11/2019
• Date Completed: 06/11/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001411-20/results