Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/11/2017 |
| Start Date: | September 2010 |
| End Date: | April 2011 |
A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A
This trial is conducted globally. The aim of this clinical trial is to investigate the
safety and pharmacokinetics (the determination of the concentration of the administered
medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with
severe haemophilia A.
safety and pharmacokinetics (the determination of the concentration of the administered
medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with
severe haemophilia A.
Inclusion Criteria:
- Haemophilia A
- Body Mass Index (BMI) below 35 kg/m2
- History of a minimum 150 exposure days (EDs) to FVIII products
(prophylaxis/prevention/surgery/on-demand)
Exclusion Criteria:
- Any history of FVIII inhibitors
- Surgery planned to occur during the trial
- Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
- Congenital or acquired coagulation disorders other than haemophilia A
We found this trial at
6
sites
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