NCT02042014

Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan

Completed Phase 3 Results posted Last updated 18 June 2019

What this trial tests

Phase 3 trial testing QTI571 in Severe Pulmonary Arterial Hypertension in 8 participants. Completed in 17 October 2016.

Timeline

22 January 2014

Primary endpoint
17 October 2016

17 October 2016

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	22 January 2014
Primary completion	17 October 2016
Estimated completion	17 October 2016
Sites	3 locations across Japan

Drugs / interventions tested

• QTI571 — full drug profile →

Conditions studied

• Severe Pulmonary Arterial Hypertension — all drugs for Severe Pulmonary Arterial Hypertension →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Severe Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Serious Adverse Events Primary · Approximately 2.9 years

All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.

Cardiac disorders (5 events)

Group	Value	95% CI
QTI571	5

Infections and infestations (5 events)

Group	Value	95% CI
QTI571	3

Resp, thoracic,mediastinal & disorder (2 events)

Group	Value	95% CI
QTI571	1

Product issues (3 events)

Group	Value	95% CI
QTI571	1

Death (none)

Group	Value	95% CI
QTI571	0

Skin & subcutaneous tissue disorder(1 event)

Group	Value	95% CI
QTI571	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected up to approximately 2.9 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

QTI571

Serious: 5/8 (63%)

Deaths: —

Serious adverse events (11 terms)

Reaction	System	QTI571
Right ventricular failure	Cardiac disorders	—
Acute myocardial infarction	Cardiac disorders	—
Supraventricular tachycardia	Cardiac disorders	—
Cellulitis	Infections and infestations	—
Gangrene	Infections and infestations	—
Respiratory tract infection	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Device connection issue	Product Issues	—
Device occlusion	Product Issues	—
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	—
Skin ulcer	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Right ventricular failure, Acute myocardial infarction, Supraventricular tachycardia, Cellulitis, Gangrene, Respiratory tract infection, Urinary tract infection, Device connection issue.

Data from ClinicalTrials.gov NCT02042014 adverse events section.

Sponsor's own description

To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.