Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin (EVOLVE)

United Therapeutics

Status: Terminated

Conditions: Pulmonary Arterial Hypertension

Treatments: Combination Product: Remunity Pump for Remodulin

Study type: Observational

Funder types: Industry

Identifiers

NCT05060315

REM-PH-417

Details and patient eligibility

About

To observe and assess drug administration activities, time spent on drug administration activities, and patient-reported outcomes (PROs) including quality of life, treatment satisfaction, and patient perception of devices related to use of United Therapeutics Corporation (UTC)-developed next-generation infusion pumps to administer Remodulin in patients with Pulmonary Arterial Hypertension (PAH).

Full description

This is a virtual, patient-centric, observational study that will follow approximately 60 participants through 8 weeks following initiation of Remodulin therapy via their UTC-developed next generation infusion pump and consists of remote and electronic assessments administered to patient via the uMotif® data capture platform at Study Enrollment, Week 2, Week 4, and Week 8 or Early Withdrawal (if applicable).

The study population will consist of 2 cohorts of PAH patients:

1. De Novo Cohort: patients new to parenteral prostacyclin-class therapy.
2. Transition Cohort: patients who had been receiving SC treprostinil therapy via a previous generation infusion pump prior to transitioning to a next generation infusion pump.

The De Novo Cohort will initiate subcutaneous (SC) Remodulin via a next generation infusion pump as prescribed by their healthcare professional. Participants will be followed from day of Study Enrollment, which will be Day 1, through 8 weeks while using next generation infusion pump, or until discontinuation of Remodulin (early withdrawal), whichever comes first.

The Transition Cohort will have previously been receiving SC treprostinil utilizing a previous generation infusion pump prior to transitioning to delivery of Remodulin via next generation infusion pump, as prescribed by their healthcare provider. Participants will be followed from day of Study Enrollment, which will be Day 1, through 8 weeks while using next generation infusion pump, or until discontinuation of Remodulin (early withdrawal), whichever comes first.

Following the completion of study assessments at Week 8 or Early Withdrawal (if applicable), participants will continue Remodulin therapy via their infusion pump at their prescriber's discretion.

Enrollment: 9 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - De Novo Cohort:

1. The patient is greater than 22 years of age at time of providing informed consent.
2. The patient is willing and able to provide informed consent and has the ability to answer surveys, questionnaires, and use the diary in English.
3. The patient has started SC Remodulin via the Remunity Pump for Remodulin (treprostinil) Injection prior to providing informed consent.
4. The patient has not been previously treated with a parenteral prostacyclin-class therapy in the past 30 days prior to initiating SC Remodulin therapy with the Remunity Pump, except in cases where the patient initiates inpatient parenteral prostacyclin-class therapy via another infusion pump and subsequently started SC Remodulin therapy with the Remunity Pump for Remodulin (treprostinil) Injection in the outpatient setting.

Inclusion Criteria - Transition Cohort:

1. The patient is greater than 22 years of age at time of providing informed consent.
2. The patient is willing and able to provide informed consent and has the ability to answer surveys, questionnaires, and use the diary in English.
3. The patient has started SC Remodulin via the Remunity Pump for Remodulin (treprostinil) Injection prior to providing informed consent.
4. The patient had been receiving continuous infusion of SC treprostinil via an infusion pump other than Remunity for at least 60 days prior to initiating SC Remodulin therapy with the Remunity Pump.

Exclusion Criteria:

1. The patient is pregnant, trying to become pregnant, or lactating.
2. For those in the Transition Cohort: The patient has a history of adverse events resulting from interruptions in their treprostinil infusions over relatively short periods (such as less than 8 hours) as they may be at higher risk in the event of pump failure, especially at night.
3. The patient is enrolled in, has participated within the last 30 days, or is planning to participate in an interventional study. Note: co-enrollment in other observational studies is permitted.
4. For those in the Transition Cohort: The patient had been receiving parenteral treprostinil via IV administration prior to transitioning to the Remunity Pump.

Trial design

9 participants in 2 patient groups

De Novo Cohort

Description:

Patients new to parenteral prostacyclin-class therapy.

Treatment:

Combination Product: Remunity Pump for Remodulin

Transition Cohort

Description:

Patients who had been receiving SC treprostinil therapy via a previous generation infusion pump prior to transitioning to a next generation infusion pump.

Treatment:

Combination Product: Remunity Pump for Remodulin