Pulmonary Arterial HypertensionPhase 3EPITOME-2NCT01431716

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

A Phase 3 study testing EFI/ACT-385781A in people with Pulmonary Arterial Hypertension, run by Actelion at 8 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: EFI/ACT-385781A
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 8 sitesin 6 countries
Study dates: Mar 2011to Jul 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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
PAH related to any condition other than those specified in the inclusion criteria

Show all 21Show fewer

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
Central venous line infection within 90 days prior to screening and/or a history of recurring line infections
Women who are pregnant or breast-feeding
Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to randomization
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months

Trial locations and contacts

8 sites in 6 countries.

Country

City, postcode or hospital

8 sites in 6 countries

Canada2 sites

Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, H3T 1 E2
University Health Network, Toronto TGH - 10 EN - 220
Toronto, Ontario, M5G 2N2

Other trials in Canada

France2 sites

Centre Hospitalier Universitaire
Caen, 14033
Hôpital Antoine Béclère
Clamart, 92141

Other trials in France

Belgium1 site

UZ Gasthuisberg
Leuven, 3000

Other trials in Belgium

Italy1 site

Orsola Malpighi
Bologna, 40138

Other trials in Italy

Netherlands1 site

VU Medisch Centrum (VUMC)
Amsterdam, 1081 HV

Other trials in Netherlands

Spain1 site

Hospital Vall d'Hebron
Barcelona, 8035

Other trials in Spain

About this study

Official title: A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial Hypertension

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
Being tested: EFI/ACT-385781A
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EFI/ACT-385781ADrug
Also called ACT-385781A, Epoprostenol for injection (EFI)

Study groups in NCT01431716
Study group	Role	What they receive
EFI/ACT-385781A	Experimental	EFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump Receives: Drug: EFI/ACT-385781A

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Jul 2012

First posted12 Sep 2011 (estimated)
Study startMar 2011
Primary completionFeb 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01431716
Sponsor's protocol ID: AC-066A301
Acronym: EPITOME-2
Status last verified: Jan 2015
First submitted: 7 Sep 2011
Last updated: 13 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT01431716
Acronym / sponsor ID: EPITOME-2 / AC-066A301
Conditions: Pulmonary Arterial Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: ActelionIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Feb 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 12 Sep 2011 (estimated)
Results: Posted 13 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EFI/ACT-385781A	Experimental	Drug: EFI/ACT-385781AEFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EFI/ACT-385781AAlso: ACT-385781A, Epoprostenol for injection (EFI)	Drug	EFI/ACT-385781A

Primary outcome

Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).
Time frame: Approximately 3 months
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.
Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).
Time frame: Approximately 3 months
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.
Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).
Time frame: Approximately 3 months
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.
Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).
Time frame: Approximately 3 months
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.
Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).
Time frame: Approximately 3 months
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.
Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).
Time frame: Approximately 3 months
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.

Results and safety

Results posted to the registry on 13 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Epoprostenol for Injection (EFI/ACT-385781A)	42	41

Primary outcome: Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).

Time frame: Approximately 3 months. Mean (Standard Deviation). Unit: dyn/sec/cm^5

Measure	EFI/ACT-385781A n = 36
Baseline	595.70 (237.14)
End of treatment	587.66 (248.44)

Population analysed: All treated set without imputation for missing values. Data was missing for 5 patients.

Primary outcome: Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).

Time frame: Approximately 3 months. Mean (Standard Deviation). Unit: dyn/sec/cm^5

Measure	EFI/ACT-385781A n = 41
Baseline	752.44 (260.91)
End of treatment	757.51 (296.82)

Population analysed: All treated set without imputation for missing values

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

Time frame: Approximately 3 months. Mean (Standard Deviation). Unit: mmHg

Measure	EFI/ACT-385781A n = 41
Baseline	51.9 (11.5)
End of treatment	51.7 (12.8)

Population analysed: All treated set without imputation for missing values

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

Time frame: Approximately 3 months. Mean (Standard Deviation). Unit: mmHg

Measure	EFI/ACT-385781A n = 41
Baseline	7.9 (4.6)
End of treatment	7.1 (4.6)

Population analysed: All treated set without imputation for missing values

Adverse events

Time frame: All adverse events (AEs) that occurred from the start of study treatment until 24 h after the end of study treatment were recorded. In addition, all serious AEs that occurred up to 30 days after the end of study treatment were also recorded.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EFI/ACT-385781A	7 of 41 (17.1%)	31 of 41 (75.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Arterial Hypertension

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
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Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EFI/ACT-385781A in people with Pulmonary Arterial Hypertension, run by Actelion at 8 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada, France, Belgium, Italy, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT). (time frame: Approximately 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01431716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.