Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-28 @ 2:59 AM
Study NCT ID:
NCT01949792
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2013-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
Sponsor:
Novo Nordisk A/S
Organization:
Study Overview
Official Title:
An Open-label Single- and Multiple-dose Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa Following i.v. Administration of One Dose of 270 Microg/kg and Three Doses of 90 Microg/kg in Patients With Haemophilia A or B With or Without Inhibitors
Status:
COMPLETED
Status Verified Date:
2014-11
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:
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: