Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603285
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
A Study to Observe the Safety Tolerability and Efficacy of Remodulin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-center Prospective Study to Observe the Safety Tolerability and Efficacy of Remodulin in Patients With Pulmonary Arterial Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center single-arm prospective study to enroll patients diagnosed as pulmonary arterial hypertension The objective in this study is to observe the efficacy and safety of treprostinil in subjects with pulmonary arterial hypertension
Detailed Description:
This is a multi-center single-arm prospective study to enroll patients diagnosed as pulmonary arterial hypertension The expected study period will be 2 years PAH patients who met NHI criteria to receive treprostinil subcutaneously intravenously will be invited to join this study for observation The dosage and administration schedule of study medication will be judged by investigators If the eligibility criteria have been met and the subject have signed the informed consent the subjects will be enrolled into this study There will be 10 visits Visit 1 Screening visit Week -2 -1 Visit 2 Week 1 initial of use treprostinil Visit 3 to 9 Week 13 to 85 Visit 10 Week 97 The Day 1 in Week 1 should be the start day of treprostinil treatment Subjects will be returned to the clinics every 3 months ie 12 weeks after Visit 2 The NT-proBNP level WHO functional class 6-minute walk distance echocardiography pulse oximetry modified Borg Dyspnea Scale SF-36 questionnaire and dosage regimens of treprostinil including dose adjustment will be collected For time to clinical worsening and death it will be followed up during study period All intercurrent events within 24 months will be recorded Safety information including vital signs and physical exams will be checked Adverse events of special interest AESIs will be reviewed every visit by using a predesignated AESI checklist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None