Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03556020
Status:
TERMINATED
Last Update Posted:
2022-08-23
First Post:
2018-06-01
Brief Title:
Phase 2 Study to Assess Safety Tolerability and Efficacy of Once Weekly SC Pemziviptadil PB1046 in Subjects With Symptomatic PAH
Sponsor:
PhaseBio Pharmaceuticals Inc
Organization:
PhaseBio Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Double-Blind Parallel Group Phase 2 Study to Assess the Safety Tolerability and Efficacy of Once Weekly Subcutaneous SC Injections of a Sustained-Release Vasoactive Intestinal Peptide VIP Analogue Pemziviptadil PB1046 in Adult Subjects With Symptomatic Pulmonary Arterial Hypertension PAH
Status:
TERMINATED
Status Verified Date:
2022-08
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
Brief Summary:
This is a multi-center randomized double-blind controlled Phase 2 study to assess the safety tolerability and efficacy of pemziviptadil PB1046 at the optimally titrated dose after 16 weeks of treatment Subjects will be randomized in a 21 ratio to one of two parallel dose groups a high-dose group where PB1046 will be up-titrated from a 02 mgkg minimally effective starting dose to a target high dose level of at least 12 mgkg or higher to a maximally tolerated dose MTD or b a low-dose group that will start at 02 mgkg and remain at this minimally effective dose MED level with sham up-titration The total treatment period will be comprised of 2 phases 1 an initial 10 week dose titration phase in which weekly doses of PB1046 will be titrated or sham titrated up to a target dose level of at least 12 mgkg or higher to the MTD and 2 a maintenance of treatment phase that begins when subjects reach week 11 and continues for 6 weeks during which no further up-titration should occur
Detailed Description:
The primary safety and tolerability objectives will be assessed by investigating the incidence and severity of adverse events AEs as well as changes from baseline in vital signs laboratory parameters ECGs and their relationship to pemziviptadil PB1046 The primary efficacy objective will be assessed by investigating the change in PVR derived from right heart catheterization RHC Secondary efficacy objectives will be assessed by investigating the impact of pemziviptadil PB1046 on change from baseline in 6 minute walk distance 6MWD test and NT-proBNP a prognostic biomarker for PAH in the two groups comparing the MTD and MED groups at the end of the treatment period In addition the effect of pemziviptadil PB1046 on other cardiopulmonary hemodynamic parameters eg CI mPAP mRAP wedge pressure and SvO2 as measured by RHC will be assessed Changes in BDI HRQoL and NYHAWHO New York Heart AssociationWorld Health Organization FC will also be assessed
An independent Data Safety Monitoring Board DSMB will periodically assess safety efficacy and biomarker data to independently assess the overall safety profile of pemziviptadil PB1046 to help adjudicate potential dose-limiting toxicities and to monitor the overall benefit risk profile of pemziviptadil PB1046 during the study The DSMB will review the safety and tolerability data after the first 10 subjects while recruitment is ongoing
An independent Data Safety Monitoring Board DSMB will periodically assess safety efficacy and biomarker data to independently assess the overall safety profile of pemziviptadil PB1046 to help adjudicate potential dose-limiting toxicities and to monitor the overall benefit risk profile of pemziviptadil PB1046 during the study The DSMB will review the safety and tolerability data after the first 10 subjects while recruitment is ongoing
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