Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT02020369
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2013-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors
Sponsor:
rEVO Biologics
Organization:
Study Overview
Official Title:
A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX
Status:
COMPLETED
Status Verified Date:
2017-05
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 the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX
Detailed Description:
This was a global, multicenter, Phase III, prospective, open-label, randomized, crossover study. After obtaining informed consent and performance of screening procedures, patients who met all inclusion and exclusion criteria were randomized to one of two treatment regimens as follows:
* 75 µg/kg treatment regimen
* 225 µg/kg treatment regimen
For each treatment regimen there were two phases:
* Phase A (Initial phase)
* Phase B (Treatment phase)
The assigned treatment regimen was the dose administered in Phase A and was the starting dose in Phase B.
* 75 µg/kg treatment regimen
* 225 µg/kg treatment regimen
For each treatment regimen there were two phases:
* Phase A (Initial phase)
* Phase B (Treatment phase)
The assigned treatment regimen was the dose administered in Phase A and was the starting dose in Phase B.
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?: