Clinical trial NCT05060315: Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin
Official title: EVOLVE: a Virtual, Observational, Patient-Centric Prospective Study to Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin to Patients with Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 9
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 60 participants in the United States will be enrolled in this study. Participants new to parenteral prostacyclin-class therapy prior to initiating next generation pump for Remodulin will be enrolled in the De Novo Cohort. Participants that had received SC treprostinil therapy via a previous generation infusion pump prior to transitioning to delivery of SC Remodulin via a next generation infusion pump will be enrolled in the Transition Cohort. The number of participants in each cohort will be assessed throughout the duration of study and may be refined accordingly.

Brief summary: 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).

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: To observe and assess time spent on drug administration activities related to the United Therapeutics Corp.-developed next generation pumps to administer Remodulin in patients with PAH
timeFrame: 8 Weeks
measure: To observe and assess patient reported outcomes via the Pulmonary Hypertension Functional Class Self-Report
timeFrame: 8 Weeks
measure: To observe and assess patient reported outcomes via the Patient Perception of Parenteral Infusion System Questionnaire
timeFrame: 8 Weeks
measure: To observe and assess patient reported outcomes via the Abbreviated Treatment Satisfaction Questionnaire for Medication
timeFrame: 8 Weeks
measure: To observe and assess patient reported outcomes via the emPHasis-10 questionnaire
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: Syneos Health
state: North Carolina
Study officials:
References: