Ignite Creation Date:
2024-05-06 @ 8:06 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02664558
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2016-01-21
Brief Title:
A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension WHO Group 1
Sponsor:
Eiger BioPharmaceuticals
Organization:
Eiger BioPharmaceuticals
Study Overview
Official Title:
A Phase 2 Randomized Double-BLInd Placebo- Controlled Study of UBEnimex in Patients With Pulmonary ARTerial HYpertension WHO Group 1 LIBERTY
Status:
COMPLETED
Status Verified Date:
2023-03
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:
LIBERTY
Brief Summary:
This proof-of-concept study is designed as a Phase 2 multicenter randomized double-blind placebo controlled study comparing ubenimex with placebo in patients with pulmonary arterial hypertension PAH World Health Organization WHO Group 1 and have a WHONew York Heart Association NYHA Functional Classification WHONYHA-FC of II or III
Detailed Description:
Ubenimex is being developed for the treatment of PAH WHO Group 1 to improve exercise capacity and delay clinical worsening This proof-of-concept study is designed as a Phase 2 multicenter randomized double-blind placebo controlled study comparing ubenimex with placebo in patients with PAH WHO Group 1 and have a WHONYHA Functional Classification WHONYHA-FC of II or III The Primary Objectives for the study are
To evaluate the efficacy of ubenimex in patients with PAH WHO Group 1
To evaluate the safety and tolerability of ubenimex in patients with WHO Group 1 PAH
To evaluate the efficacy of ubenimex in patients with PAH WHO Group 1
To evaluate the safety and tolerability of ubenimex in patients with WHO Group 1 PAH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None