An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)

An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018320-10-BE

Enrollment

Registered

2010-04-13

Start date

2010-07-02

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: EPOPROSTENOL SODIUM

Eligibility

Sex/Gender

All

Inclusion criteria

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 (i.e. reimbursement) to commercial EFI at the time of ending participation in study AC-066A301 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 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

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
Main Objective: To assess safety and tolerability of Epoprostenol for injection in patients with PAH ;Secondary Objective: NA;Primary end point(s): Tolerability / Safety endpoints: • Treatment-emergent adverse events (AEs) up to 24 hours post-EOT • Adverse events leading to premature discontinuation of study drug • Treatment-emergent serious AEs (SAEs) up to 30 days post-EOT ;Timepoint(s) of evaluation of this end point: - Monthly phone call during the study - End-of-Study Treatment (EOT) visit - 24 hours following EOT (phone call) - 30 days following EOT (phone call)	—

Measure

Time frame

Main Objective: To assess safety and tolerability of Epoprostenol for injection in patients with PAH ;Secondary Objective: NA;Primary end point(s): Tolerability / Safety endpoints: • Treatment-emergent adverse events (AEs) up to 24 hours post-EOT • Adverse events leading to premature discontinuation of study drug • Treatment-emergent serious AEs (SAEs) up to 30 days post-EOT ;Timepoint(s) of evaluation of this end point: - Monthly phone call during the study - End-of-Study Treatment (EOT) visit - 24 hours following EOT (phone call) - 30 days following EOT (phone call)

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Belgium, Canada, France, Italy, Netherlands, Spain

Contacts

Public ContactGlobal Medical Information

ACTELION Pharmaceuticals Ltd

medinfo_ch@actelion.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026