drugset / Trial / NCT02930317

Evaluate Efficacy and Safety of Recombinant Factor VIII (rFVIII)Treatment of Severe or Moderately Severe Hemophilia A

NCT02930317

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Efficacy, Safety and Pharmacokinetics Study of a rFVIII in Chinese subjects with Hemophilia A.To assess efficacy and safety of rFVIII administered as treatment and as on-demand therapy in adult and adolescent (12-65 years) patients with severe or moderately severe Hemophilia A. To determine the pharmacokinetic (PK) parameters of rFVIII.

Timeline

Start
2016-08
Primary completion
2017-10
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject ADVATE Protein / enzyme biologic 50 iu/kg Intravenous

Indications