Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A

Summary

The purpose of this study is to obtain additional data on the safety and efficacy of Wilate in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs, thus supplementing the existing database to obtain approval of Wilate for the indication hemophilia A in the USA.

Timeline

Start

2016-12

Primary completion

2018-03-29

Completion

2018-03-29

Outcome

Met primary endpoint

registry analysis (other test); Wilate; p <0.0001; Poisson test estimate 2.13 (95% CI 1.64 to 2.76); Poisson test estimate; note: versus mean TABR \>29 NCT02954575 ↗

Drugs

Indications