Pulmonary Arterial Hypertension
Conditions
Brief summary
This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.
Interventions
DRUGEpoprostenol
Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit
Sponsors
Chiltern International Ltd.
Effi-Stat
Actelion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent prior to initiation of any study-mandated procedure 2. Patients who completed participation in study AC-066A301 3. Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301
Exclusion criteria
1. Patients who prematurely discontinued study drug in study AC-066A301 2. Patients for whom continued treatment with EFI is no longer considered appropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent Adverse Events | On average 2.72 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exposure Duration | On average 2.72 years | Duration of exposure to EFI |
Participant flow
Recruitment details
Extension study for patients who completed EPITOME-2 (AC-066A301). Patients continued to receive EFI (epoprostenol sodium). In 6 countries (FR, CA, BE, NL, IT, ES) at 8 expert centers for the treatment of patients with pulmonary arterial hypertension. Recruitment started on 15 June 2011 and was completed on 02 February 2012.
Participants by arm
| Arm | Count |
|---|---|
| Treatment All patients who received at least one dose of EFI | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 1 |
| Overall Study | Lung transplant | 6 |
| Overall Study | Patient's and investigator's decision | 1 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 46.0 Years |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / 41 |
| serious Total, serious adverse events | 35 / 41 |
Outcome results
Primary
Treatment-emergent Adverse Events
Time frame: On average 2.72 years
Population: All patients who received at least one dose of EFI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Treatment-emergent Adverse Events | 41 Number of patients |
Secondary
Exposure Duration
Duration of exposure to EFI
Time frame: On average 2.72 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Exposure Duration | 2.44 year |