Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05060315
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-18
First Post:
2021-04-06
Brief Title:
Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVOLVE
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 prescribers discretion
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 prescribers discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None