Trials / Completed
CompletedNCT01561924
Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography
An Exploratory Non-interventional Study of Ex-vivo Spiking Followed by Thromboelastography as a Method for Predicting the Efficacy of Recombinant Activated Human FVII (rFVIIa, NovoSeven®) in Adult Congenital Haemophilia A or B Patients With Inhibitors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.
Detailed description
The TEG parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | eptacog alfa (activated) | Subjects will be called to attend the clinic in a non-bleeding state. Blood samples will be drawn for thromboelastogram profiling and will be in-vitro spiked with different doses of activatated recombinant human factor VII. |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2006-05-01
- Completion
- 2006-05-01
- First posted
- 2012-03-23
- Last updated
- 2016-11-23
Locations
7 sites across 4 countries: United States, Denmark, France, United Kingdom
Source: ClinicalTrials.gov record NCT01561924. Inclusion in this directory is not an endorsement.