Trials / Completed
CompletedNCT01949792
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Congenital Bleeding Disorder
- Haemophilia A
- Haemophilia A With Inhibitors
- Haemophilia B
- Haemophilia B With Inhibitors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | eptacog alfa (activated) | Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®) |
| DRUG | eptacog alfa (activated) | Subject will receive 3 injections (i.v.) of 90 microg/kg rFVIIa (NovoSeven®) over a 6 hour period (each injection will be separated by 3 hours) |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2013-09-25
- Last updated
- 2014-11-14
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01949792. Inclusion in this directory is not an endorsement.