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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	22 Years and Over
Gender	All

More Inclusion & 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.

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05060315
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	United Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension

Additional Details

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.

Arms & Interventions

Arms

: De Novo Cohort

Patients new to parenteral prostacyclin-class therapy.

: 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.

Interventions

Combination Product: - Remunity Pump for Remodulin

Participants on the study will receive Remodulin via the Remunity Pump with dosing and titration managed at the discretion of the prescribing healthcare professional. Dosing and titration of Remodulin will in no way be influenced by the participation in this study or this protocol.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Syneos Health, Morrisville, North Carolina

Status

Address

Syneos Health

Morrisville, North Carolina, 27560

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