Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

Actelion41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

EpoprostenolDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment-emergent Adverse Events

Time frame: On average 2.72 years

Secondary Outcomes

Exposure Duration

Duration of exposure to EFI

Time frame: On average 2.72 years

Data from ClinicalTrials.gov

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