Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension (Epitome2ext)

An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)

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 Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: Epoprostenol

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Uz Gasthuisberg
• Canada
  • Ontario
    • Toronoto, Ontario, Canada, M5G 2N2
      • University of Toronto
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer B Davis Jewish General Hospital
• France
  • Caen, France
    • CHU caen
  • Paris, France
    • Hopital Kremlin Bicetre
• Italy
  • Bologna, Italy, 40438
    • Ospedale Sant'Orsola
• Netherlands
  • Amsterdam, Netherlands
    • VUMC
• Spain
  • Madrid, Spain
    • Hospital 12 de Octubre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Single arm, open-label	Drug: Epoprostenol; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent Adverse Events	On average 2.72 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exposure Duration	Duration of exposure to EFI	On average 2.72 years

Collaborators and Investigators

• Sponsor: Actelion
• Collaborators: Chiltern International Ltd.; Effi-Stat

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (Estimate): November 11, 2011

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Antihypertensive Agents; Vasodilator Agents; Platelet Aggregation Inhibitors; Epoprostenol; Tezosentan
• Other Study ID Numbers: AC-066A302