Ignite Creation Date:
2024-05-06 @ 12:33 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03795428
Status:
TERMINATED
Last Update Posted:
2022-02-22
First Post:
2018-12-18
Brief Title:
Long-Term Open Label Extension Study of Pemziviptadil PB1046 in PAH Subjects Following Completion of Study PB1046-PT-CL-0004
Sponsor:
PhaseBio Pharmaceuticals Inc
Organization:
PhaseBio Pharmaceuticals Inc
Study Overview
Official Title:
A Long-Term Open Label Extension Study of Pemziviptadil PB1046 Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated Study drug resupply delayed Covid-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP Extend
Brief Summary:
This is a multi-center Phase 2 Long-Term Open Label Extension OLE Study to assess the safety and tolerability of pemziviptadil PB1046 at an optimally titrated dose This is a Long-Term Open label Extension OLE Study for subjects with PAH having participated in double-blind Study PB1046-PT-CL-0004 The study will include adult subjects previously diagnosed with symptomatic PAH who are receiving background clinician-directed therapy for PAH
During this period subjects will continue to be followed for safety and tolerability as well as for periodic efficacy quality of life data and immunogenicity The study will continue per the schedule of events until such time when pemziviptadil PB1046 is able to be self-administered becomes commercially available to the subjects in a particular country or region or the sponsor terminates the study due to lack of efficacy safety or other reasons
During this period subjects will continue to be followed for safety and tolerability as well as for periodic efficacy quality of life data and immunogenicity The study will continue per the schedule of events until such time when pemziviptadil PB1046 is able to be self-administered becomes commercially available to the subjects in a particular country or region or the sponsor terminates the study due to lack of efficacy safety or other reasons
Detailed Description:
Subjects entering this study will enter from the double-blind Study PB1046-PT-CL-0004 The starting dose level of pemziviptadil PB1046 for all subjects in this parent study was a sub-therapeutic or minimally effective dose MED of 02 mgkg administered by SC injection
Subjects were randomized into the MED Group or a dose-titration group In the dose-titration group individual subjects were titrated up to their maximum tolerated dose MTD in a blinded fashion with the objective of titrating subjects up to a dose of at least 12 mgkg or higher in the MTD Group while subjects in the MED Group remained at the MED level of 02 mgkg and underwent sham dose-titration to maintain the blind
Subjects entering the 0006 trial prior to implementation of this protocol amendment will remain blinded until such time that open label dosing will not unblind the 0004 study
Subjects were randomized into the MED Group or a dose-titration group In the dose-titration group individual subjects were titrated up to their maximum tolerated dose MTD in a blinded fashion with the objective of titrating subjects up to a dose of at least 12 mgkg or higher in the MTD Group while subjects in the MED Group remained at the MED level of 02 mgkg and underwent sham dose-titration to maintain the blind
Subjects entering the 0006 trial prior to implementation of this protocol amendment will remain blinded until such time that open label dosing will not unblind the 0004 study
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