Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT02670720
Status:
TERMINATED
Last Update Posted:
2016-02-17
First Post:
2016-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema
Sponsor:
BioCryst Pharmaceuticals
Organization:
Study Overview
Official Title:
OPuS-4: An Open-label Study to Evaluate the Long-term Safety of Avoralstat in Subjects With Hereditary Angioedema
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
preceding efficacy study of avoralstat in its current formulation was not significant and does not support continued development
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPuS-4
Brief Summary:
This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: