Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension

NCT01431716 | Completed Phase 3 Results

• 1 other identifier: AC-066A301
• Study Type: interventional
• Target: 42
• Locations: 6 countries
• Sites: 8

Brief Summary

This study is investigating the effect of switching from Flolan® to Epoprostenol for Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated with Flolan®. For this purpose patients being treated for at least 12 months with Flolan® will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety, tolerability, efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients with pulmonary arterial hypertension.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (6)

• Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).

  Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

  Approximately 3 months

• Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).

  Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

  Approximately 3 months

• Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).

  Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

  Approximately 3 months

• Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).

  Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

  Approximately 3 months

• Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).

  Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

  Approximately 3 months

• Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).

  Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

  Approximately 3 months

Other Outcomes (8)

• Change in 6-minute Walk Distance (6MWD) From Baseline to EOT.

  Approximately 3 months

• Change in Borg Dyspnea Score From Baseline to EOT.

  Approximately 3 months

• Number of Participants With Improved, No Change, or Worsening of New York Heart Association Functional Class (NYHA FC) From Baseline to EOT.

  Approximately 3 months

Study Arms (1)

EFI/ACT-385781A

EXPERIMENTAL

EFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump

Drug: EFI/ACT-385781A

Interventions

EFI/ACT-385781A DRUG

Also known as: ACT-385781A, Epoprostenol for injection (EFI)

EFI/ACT-385781A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 years and above
• Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I: Idiopathic (IPAH), Heritable (HPAH), Associated (APAH) with Connective tissue diseases or Drugs and toxins
• Patients treated with Flolan® for at least 12 months and on a stable dose for at least 3 months prior to enrollment
• Patients who are currently treated with concomitant PAH therapy listed below must have been treated for at least 90 days and on a stable dose for 30 days prior to enrollment: Bosentan, Ambrisentan, Sitaxsentan, Sildenafil, Tadalafil
• Women of childbearing potential must use a reliable method of contraception
• Signed informed consent prior to initiation of any study mandated procedure

You may not qualify if:

• Patients with respiratory and/or cardiovascular distress in need of emergency care
• Known or suspicion of pulmonary veno-occlusive disease (PVOD)
• Current use of IV inotropic agents
• Current use of any prostacyclin or prostacyclin analog other than Flolan®
• Tachycardia with heart rate \> 120 beats/min at rest
• Known hypersensitivity to the formulations EFI/ACT-385781A or any of its excipients, and Flolan® or any of its excipients
• Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
• History of myocardial infarction
• History of left-sided heart disease, including any of the following:
• hemodynamically significant aortic or mitral valve disease
• restrictive or congestive cardiomyopathy
• left ventricular ejection fraction \< 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
• unstable angina pectoris
• life-threatening cardiac arrhythmias
• Chronic bleeding disorders

Sponsors & Collaborators

• Actelion: lead

Study Sites (8)

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

University Health Network, Toronto TGH - 10 EN - 220

Toronto, Ontario, M5G 2N2, Canada

Location

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, H3T 1 E2, Canada

Location

Centre Hospitalier Universitaire

Caen, 14033, France

Location

Hôpital Antoine Béclère

Clamart, 92141, France

Location

Orsola Malpighi

Bologna, 40138, Italy

Location

VU Medisch Centrum (VUMC)

Amsterdam, 1081 HV, Netherlands

Location

Hospital Vall d'Hebron

Barcelona, 8035, Spain

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Epoprostenol; Injections

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins I; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Thomas Pfister, PhD, Senior Clinical Scientist
• Organization: Actelion Pharmaceuticals Ltd

thomas.pfister@actelion.com

+41 61 565 5932

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 12, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 13, 2015
• Results First Posted: January 13, 2015

Record last verified: 2015-01

Locations

IT (1); BE (1); NL (1); ES (1); CA (2); FR (2)