Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04125745
Status:
TERMINATED
Last Update Posted:
2022-01-12
First Post:
2018-08-28
Brief Title:
Oral CXA-10 in Pulmonary Arterial Hypertension
Sponsor:
Gladwin Mark MD
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
negative study outcome from Complexas multicenter clinical trial no safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAH
Brief Summary:
The main objective of this study is to evaluate the safety and tolerability of 12-week oral CXA-10 therapy in subjects with pulmonary arterial hypertension with additional evaluation on the clinical efficacy of oral CXA-10 on changes in hemodynamics exercise capacity cardiovascular function and patient reported outcomes
Detailed Description:
This is a single-center one-arm open-label proof of concept safety study and a phase 2a proof of efficacy pre- and post-assessment study of oral CXA-10 for the treatment of pulmonary arterial hypertension
The investigators hypothesize that administration of CXA-10 for 12 weeks will improves exercise capacity cardiovascular function and health related quality of life in pulmonary arterial hypertension patients with limited toxicity
Subjects who meet the inclusion criteria and none of the exclusion criteria will be scheduled within 4 weeks of screening to receive oral CXA-10 at the dose of 300 mg once daily followed by 12 weeks of open-label CXA-10 treatment and then a 4-week safety follow-up Additional follow-up assessments by telephone will occur in between each outpatient clinic visit
The investigators hypothesize that administration of CXA-10 for 12 weeks will improves exercise capacity cardiovascular function and health related quality of life in pulmonary arterial hypertension patients with limited toxicity
Subjects who meet the inclusion criteria and none of the exclusion criteria will be scheduled within 4 weeks of screening to receive oral CXA-10 at the dose of 300 mg once daily followed by 12 weeks of open-label CXA-10 treatment and then a 4-week safety follow-up Additional follow-up assessments by telephone will occur in between each outpatient clinic visit
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01HL103455 | NIH | None | httpsreporternihgovquickSearchP01HL103455 |