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

NCT ID: NCT03016468

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2018-09-30

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parenteral Remodulin then Oral Treprostinil

Group Type: EXPERIMENTAL

Parenteral Remodulin (treprostinil) injection

Intervention Type: DRUG

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 Treprostinil

Intervention Type: DRUG

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.

Interventions

Parenteral Remodulin (treprostinil) injection

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

Oral Treprostinil

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.

Intervention Type: DRUG

Other Intervention Names

Remodulin; Orenitram

Eligibility Criteria

Inclusion Criteria

1. 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.

2. The subject must be classified as WHO FC II or III at Baseline.

3. The subject is receiving selexipag for the treatment of WHO Group 1 PAH for a minimum of 90 days from Baseline.

4. Subject is in need of escalation of therapy, as determined by the Investigator.

5. 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

1. The subject is receiving selexipag for any other disease or condition other than the treatment of WHO Group 1 PAH.

2. The subject has a Baseline 6MWD of less than 150 meters.

3. The subject's Baseline 6MWD has decreased more than 40% from the pre-selexipag baseline.

4. 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%.

5. The subject has previously been treated with any parenteral prostacyclin or oral treprostinil for a period of 90 days or more.

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TDE-PH-207

Identifier Type: -

Identifier Source: org_study_id