Ignite Creation Date:
2024-05-06 @ 1:32 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04053543
Status:
TERMINATED
Last Update Posted:
2020-08-26
First Post:
2019-07-19
Brief Title:
CXA-10 Study in Subjects With Pulmonary Arterial Hypertension
Sponsor:
Complexa Inc
Organization:
Complexa Inc
Study Overview
Official Title:
A Phase 2 Multi-Center Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy Extension to Study CXA-10-301
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
LOE
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 multicenter open-label extension OLE of study CXA-10-301 to evaluate the long term safety and efficacy of daily dosing of CXA-10
Detailed Description:
This is a Phase 2 multicenter open-label extension OLE of study CXA-10-301 to evaluate the long term safety and efficacy of daily dosing of CXA-10
The study will be performed in approximately 50 study centers across the United States and the United Kingdom which participated in CXA-10-301 Approximately 96 subjects who completed treatment in CXA-10-301 will be eligible to participate in this OLE study after completing all Visit 9 Day 1 and Day 2 assessments in CXA-10-301
Study participation for each subject will last up to approximately 65 months The study will consist of a 6 month open-label treatment period and require 5 clinic visits and 1 telephone visit including the Baseline Visit completed simultaneously with Visit 9 CXA-10-301 plus a follow-up visit approximately 2 weeks following the last dose of CXA-10
The study will be performed in approximately 50 study centers across the United States and the United Kingdom which participated in CXA-10-301 Approximately 96 subjects who completed treatment in CXA-10-301 will be eligible to participate in this OLE study after completing all Visit 9 Day 1 and Day 2 assessments in CXA-10-301
Study participation for each subject will last up to approximately 65 months The study will consist of a 6 month open-label treatment period and require 5 clinic visits and 1 telephone visit including the Baseline Visit completed simultaneously with Visit 9 CXA-10-301 plus a follow-up visit approximately 2 weeks following the last dose of CXA-10
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