Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02764489
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2016-04-11
Brief Title:
FEIBA Reconstitution Volume Reduction and Faster Infusion Study FEIBA STAR
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 3b4 Prospective Multicenter Open-label Randomized Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50 Reduced Volume and of Faster Infusion Rates in Patients With Hemophilia A or B With Inhibitors
Status:
COMPLETED
Status Verified Date:
2023-02
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 purpose of this study is to
1 To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity FEIBA at the standard infusion rate of 2 Ukgmin
2 To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 Ukgmin in comparison to the standard rate of 2 Ukgmin at the regular volume
1 To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity FEIBA at the standard infusion rate of 2 Ukgmin
2 To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 Ukgmin in comparison to the standard rate of 2 Ukgmin at the regular volume
Detailed Description:
15 JUN 2020 The temporary enrollment stop of new patients into this study due to the COVID-19 pandemic has been lifted in one or more countriessites and the study is now again enrolling new patients However some countriessites may still have paused the enrollment of new patients due to the pandemic
23 APRIL 2020 Enrollment of new patients into this study has been paused due to the COVID-19 situation The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic
23 APRIL 2020 Enrollment of new patients into this study has been paused due to the COVID-19 situation The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic
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 |
|---|---|---|---|
| 2015-005781-39 | EUDRACT_NUMBER | None | None |