Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02736149
Status:
TERMINATED
Last Update Posted:
2023-01-18
First Post:
2016-04-04
Brief Title:
Open-Label Extension 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 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Ubenimex in Patients With Pulmonary Arterial Hypertension WHO Group 1
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Following the failure to demonstrate efficacy in EIG-UBX-001 the sponsor decided to terminate Study EIG-UBX-002
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIBERTY2
Brief Summary:
Ubenimex is being developed for the treatment of pulmonary arterial hypertension PAH World Health Organization WHO Group 1 to improve exercise capacity and delay clinical worsening
This study is a Phase 2 open-label extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH WHO Group 1 who complete Study EIG-UBX-001
This study is a Phase 2 open-label extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH WHO Group 1 who complete Study EIG-UBX-001
Detailed Description:
This study is a Phase 2 open-label multicenter extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH WHO Group 1 who complete Study EIG-UBX-001 Study EIG-UBX-001 is a Phase 2 randomized double-blind placebo-controlled clinical trial and meet the eligibility criteria for Study EIG-UBX-002 The primary objective for this study is
- to obtain long-term safety and tolerability data for ubenimex 150 mg administered three times daily TID in patients with PAH WHO Group 1
- to obtain long-term safety and tolerability data for ubenimex 150 mg administered three times daily TID in patients with PAH WHO Group 1
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