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

Terminated

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Combination Product: Remunity Pump for Remodulin

• Registration Number: NCT05060315
• Lead Sponsor: United Therapeutics

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.

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-29
• Study Start: 2023-07-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transition Cohort	Remunity Pump for Remodulin	Patients who had been receiving SC treprostinil therapy via a previous generation infusion pump prior to transitioning to a next generation infusion pump.
De Novo Cohort	Remunity Pump for Remodulin	Patients new to parenteral prostacyclin-class therapy.

Primary Outcome Measures

Name	Time	Method
To observe and assess patient reported outcomes via the emPHasis-10 questionnaire	8 Weeks	The emPHasis-10 questionnaire is a reliable and validated tool for assessment of health-related quality of life in pulmonary hypertension. It consists of 10 items, which address breathlessness, fatigue, control, and confidence.
To observe and assess patient reported outcomes via the Pulmonary Hypertension Functional Class Self-Report	8 Weeks	Participant self-assessment of Functional Class (I to IV) will be performed using the Pulmonary Hypertension Functional Class Self-Report (PH-FC-SR), as adapted from the pulmonary hypertension World Health Organization Functional Classification System.
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	8 Weeks	Participants will be asked to participate in a comprehensive collection of the drug administration activities data consisting of a 7-day evaluation period of daily drug administration activities pertaining to their next generation infusion pump via the Drug Administration Activities Diary.
To observe and assess patient reported outcomes via the Patient Perception of Parenteral Infusion System Questionnaire	8 Weeks	The Patient Perception of Parenteral Infusion System Questionnaire will be administered to assess the participant's perception of their infusion pumps.
To observe and assess patient reported outcomes via the Abbreviated Treatment Satisfaction Questionnaire for Medication	8 Weeks	The Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a validated instrument to assess participants' satisfaction with medication, providing scores on 3 scales - effectiveness, convenience, and global satisfaction.

Trial Locations

Locations (1)

Syneos Health; 🇺🇸 Morrisville, North Carolina, United States