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

Primary Purpose

Pulmonary Arterial Hypertension

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Parenteral Remodulin (treprostinil) injection

Oral Treprostinil

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Oral Treprostinil, Remodulin, Selexipag, 6 Minute Walk Test

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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:
1. Total lung capacity less than 60% of predicted normal.
2. Forced expiratory volume in 1 second is less than 55% of predicted normal.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parenteral Remodulin then Oral Treprostinil

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs) through 16 Weeks

Secondary Outcome Measures

Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16

Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16

Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16

Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16

Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16

Full Information

NCT ID

NCT03016468

First Posted

January 6, 2017

Last Updated

April 7, 2017

Sponsor

United Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03016468

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Business decision

Study Start Date

May 2017 (Anticipated)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. The treatment phase of the study will last approximately 16 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

Keywords

Oral Treprostinil, Remodulin, Selexipag, 6 Minute Walk Test

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Parenteral Remodulin then Oral Treprostinil

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Parenteral Remodulin (treprostinil) injection

Other Intervention Name(s)

Remodulin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Oral Treprostinil

Other Intervention Name(s)

Orenitram

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of Adverse Events (AEs) through 16 Weeks

Time Frame

16 Weeks

Secondary Outcome Measure Information:

Title

Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16

Time Frame

Baseline and Week 16

Title

Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16

Time Frame

Baseline and Week 16

Title

Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16

Time Frame

Baseline and Week 16

Title

Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16

Time Frame

Baseline and Week 16

Title

Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16

Time Frame

Baseline and Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

12. IPD Sharing Statement

Learn more about this trial

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

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