Trials / Completed
CompletedNCT01562587
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non-Bleeding State
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 3 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | activated recombinant human factor VII | A single bolus dose is administered. Injected intravenously |
| DRUG | activated recombinant human factor VII | A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously |
Timeline
- Start date
- 2002-09-01
- Primary completion
- 2003-05-01
- Completion
- 2003-05-01
- First posted
- 2012-03-26
- Last updated
- 2017-01-12
Locations
8 sites across 5 countries: Germany, Greece, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01562587. Inclusion in this directory is not an endorsement.