drugset / Trial / NCT02256917
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
NaSingle-groupOpen-labelPrevention
Summary
The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.
Timeline
- Start
- 2015-05
- Primary completion
- 2018-09
- Completion
- 2018-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | simoctocog alfa | Protein / enzyme biologic | — | — |