Pulmonary Arterial HypertensionPhase 2NCT03016468

Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH

A Phase 2 study testing Parenteral Remodulin (treprostinil) injection and Oral Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

This is a multicenter, single-arm trial to evaluate the safety of the transition from Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10 clinical trial centers. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: Parenteral Remodulin (treprostinil) injection and Oral Treprostinil
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: May 2017to Sep 2018
Phase: Phase 2
Are there results?: None posted in the registry

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has a diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with connective tissue disease, PAH associated with HIV infection, PAH associated with repaired congenital systemic-to-pulmonary shunt (at least 1 year since repair with respect to the date of providing informed consent), or PAH associated with appetite suppressant or toxin use.
The subject must be classified as WHO FC II or III at Baseline.
The subject is receiving selexipag for the treatment of WHO Group 1 PAH for a minimum of 90 days from Baseline.
Subject is in need of escalation of therapy, as determined by the Investigator.
Subject must be receiving a Food and Drug Administration (FDA)-approved PDE5-I or sGC stimulator and/or an ERA and has been at the current stable dose for at least 28 days prior to Baseline.

Who cannot join

The subject is receiving selexipag for any other disease or condition other than the treatment of WHO Group 1 PAH.
The subject has a Baseline 6MWD of less than 150 meters.
The subject's Baseline 6MWD has decreased more than 40% from the pre-selexipag baseline.
The subject has a history of ischemic heart disease (defined as either symptomatic or requiring anti-anginal therapy or experienced a documented myocardial infarction within the previous 6 months of Baseline), or a history of left sided myocardial dysfunction as evidenced by a PAWP greater than 15 mmHg or a left ventricular ejection fraction less than 40%.
The subject has previously been treated with any parenteral prostacyclin or oral treprostinil for a period of 90 days or more.
The subject has a history of 1 or more of the following signs of relevant lung disease within 180 days before Baseline:
Total lung capacity less than 60% of predicted normal.
Forced expiratory volume in 1 second is less than 55% of predicted normal.

About this study

Official title: A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension

Conditions: Pulmonary Arterial Hypertension
Being tested: Parenteral Remodulin (treprostinil) injection, Oral Treprostinil
Keywords: Oral Treprostinil, Remodulin, Selexipag, 6 Minute Walk Test
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.

Parenteral Remodulin (treprostinil) injectionDrug
Also called Remodulin
Remodulin will be provided in vial strengths of 1, 2.5, 5, and 10 mg/mL. Subjects will be admitted to the hospital and IV Remodulin will be initiated within 12 hours after the last dose of selexipag. Subjects will remain under observation in the inpatient setting for at least the first 72 hours of Remodulin administration. Subjects will be transitioned to an equivalent dose of SC Remodulin at discharge.
Oral TreprostinilDrug
Also called Orenitram
Oral treprostinil will be provided as 0.125-, 0.25-, 1-, or 2.5-mg extended-release tablets. Oral treprostinil will be dosed three times daily with food.

Study groups in NCT03016468
Study group	Role	What they receive
Parenteral Remodulin then Oral Treprostinil	Experimental	Not described Receives: Drug: Parenteral Remodulin (treprostinil) injection; Drug: Oral Treprostinil

What is being measured

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

Incidence of Adverse Events (AEs) through 16 Weeks
Measured: 16 Weeks

Secondary outcomes (5)

Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16
Measured: Baseline and Week 16
Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16
Measured: Baseline and Week 16
Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16
Measured: Baseline and Week 16
Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16
Measured: Baseline and Week 16
Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16
Measured: Baseline and Week 16

Timeline

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

May 2017Sep 2018

First posted10 Jan 2017 (estimated)
Study startMay 2017 (estimated)
Primary completionSep 2018 (estimated)
Study completionSep 2018 (estimated)

Why it stopped: Business decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
More trials run by United TherapeuticsThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03016468
Sponsor's protocol ID: TDE-PH-207
Status last verified: Apr 2017
First submitted: 6 Jan 2017
Last updated: 11 Apr 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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?

Official record

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
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH

All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT03016468
Acronym / sponsor ID: TDE-PH-207
Conditions: Pulmonary Arterial Hypertension
Keywords: Oral Treprostinil, Remodulin, Selexipag, 6 Minute Walk Test
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Business decision
Enrolment: 0 participants (actual)
Lead sponsor: United TherapeuticsIndustry (pharma, biotech, devices)
Study start: May 2017 (estimated)
Primary completion: Sep 2018 (estimated)
Study completion: Sep 2018 (estimated)
First posted: 10 Jan 2017 (estimated)
Results: Not posted in the source record

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
Parenteral Remodulin then Oral Treprostinil	Experimental	Drug: Parenteral Remodulin (treprostinil) injection, Drug: Oral Treprostinil

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject has a diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with connective tissue disease, PAH associated with HIV infection, PAH associated with repaired congenital systemic-to-pulmonary shunt (at least 1 year since repair with respect to the date of providing informed consent), or PAH associated with appetite suppressant or toxin use.
The subject must be classified as WHO FC II or III at Baseline.
The subject is receiving selexipag for the treatment of WHO Group 1 PAH for a minimum of 90 days from Baseline.
Subject is in need of escalation of therapy, as determined by the Investigator.
Subject must be receiving a Food and Drug Administration (FDA)-approved PDE5-I or sGC stimulator and/or an ERA and has been at the current stable dose for at least 28 days prior to Baseline.

Key exclusion criteria (8 listed)

The subject is receiving selexipag for any other disease or condition other than the treatment of WHO Group 1 PAH.
The subject has a Baseline 6MWD of less than 150 meters.
The subject's Baseline 6MWD has decreased more than 40% from the pre-selexipag baseline.
The subject has a history of ischemic heart disease (defined as either symptomatic or requiring anti-anginal therapy or experienced a documented myocardial infarction within the previous 6 months of Baseline), or a history of left sided myocardial dysfunction as evidenced by a PAWP greater than 15 mmHg or a left ventricular ejection fraction less than 40%.
The subject has previously been treated with any parenteral prostacyclin or oral treprostinil for a period of 90 days or more.

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
Parenteral Remodulin (treprostinil) injectionAlso: RemodulinRemodulin will be provided in vial strengths of 1, 2.5, 5, and 10 mg/mL. Subjects will be admitted to the hospital and IV Remodulin will be initiated within 12 hours after the last dose of selexipag. Subjects will remain under observation in the inpatient setting for at least the first 72 hours of Remodulin administration. Subjects will be transitioned to an equivalent dose of SC Remodulin at discharge.	Drug	Parenteral Remodulin then Oral Treprostinil
Oral TreprostinilAlso: OrenitramOral treprostinil will be provided as 0.125-, 0.25-, 1-, or 2.5-mg extended-release tablets. Oral treprostinil will be dosed three times daily with food.	Drug	Parenteral Remodulin then Oral Treprostinil

Primary outcome

Incidence of Adverse Events (AEs) through 16 Weeks
Time frame: 16 Weeks

5 secondary outcomes

Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16
Time frame: Baseline and Week 16
Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16
Time frame: Baseline and Week 16
Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16
Time frame: Baseline and Week 16
Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16
Time frame: Baseline and Week 16
Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16
Time frame: Baseline and Week 16

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.

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
Pulmonary Disease, Pulmonary Hypertension
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Parenteral Remodulin (treprostinil) injection and Oral Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics.

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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of Adverse Events (AEs) through 16 Weeks (time frame: 16 Weeks). 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 NCT03016468.

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 11 Apr 2017.