drugset / Trial / NCT02256917

Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A

NCT02256917

Phase 3 Completed 58 enrolled Octapharma
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

EvaluationDrugModalityDoseRoute
Subject simoctocog alfa Protein / enzyme biologic

Indications