Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03315507
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2017-10-02
Brief Title:
A Study to Assess the Safety Tolerability and Hemodynamic Response of PB1046 in Subjects With PAH
Sponsor:
PhaseBio Pharmaceuticals Inc
Organization:
PhaseBio Pharmaceuticals Inc
Study Overview
Official Title:
An Open-Label Dose Titration Study to Assess the Safety Tolerability and Hemodynamic Response of PB1046 A Sustained-Release Analogue of Vasoactive Intestinal Peptide In Adult Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2019-10
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:
None
Brief Summary:
PB1046-PT-CL-0005 is an open-label dose-titration study to assess the safety tolerability and hemodynamic effects of individually dose-titrated PB1046 administered by weekly subcutaneous injection for 8 weeks in adult subjects with PAH who have a permanently implanted hemodynamic monitor in the distal pulmonary artery The primary objectives of the study are to assess the overall safety tolerability and hemodynamic profile of a PB1046 across an individually titrated dose range
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None