Severe Pulmonary Arterial Hypertension
Conditions
Keywords
Pulmonary arterial hypertension, QTI571, open label study
Brief summary
To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.
Detailed description
This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.
Interventions
DRUGQTI571
QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH) and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan. * Patient is currently benifitting form the treatment with QTI571 in the opinion of the investigator.
Exclusion criteria
* Patient has been permanently discontinued from QTI571 study treatment in the parent study. * Concomitant use of oral vitamin K antagonist medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 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. |
Countries
Japan
Participant flow
Recruitment details
8 participants entered this study after completing the CQTI571A2301E1 study. All 8 participants discontinued study prematurely.
Participants by arm
| Arm | Count |
|---|---|
| QTI571 Participants received QTI571 during 3 years. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 7 |
Baseline characteristics
| Characteristic | QTI571 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 5 / 8 |
Outcome results
Primary
Serious Adverse Events
All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.
Time frame: Approximately 2.9 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QTI571 | Serious Adverse Events | Cardiac disorders (5 events) | 5 participants |
| QTI571 | Serious Adverse Events | Infections and infestations (5 events) | 3 participants |
| QTI571 | Serious Adverse Events | Resp, thoracic,mediastinal & disorder (2 events) | 1 participants |
| QTI571 | Serious Adverse Events | Product issues (3 events) | 1 participants |
| QTI571 | Serious Adverse Events | Death (none) | 0 participants |
| QTI571 | Serious Adverse Events | Skin & subcutaneous tissue disorder(1 event) | 1 participants |