Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-03-03 @ 6:04 PM
Study NCT ID:
NCT02246868
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2014-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Sponsor:
Bio Products Laboratory
Organization:
Study Overview
Official Title:
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Status:
COMPLETED
Status Verified Date:
2018-02
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:
None
Brief Summary:
The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: