FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis

Summary

This is a phase 3, multi-center, prospective, open-label, single-arm, clinical trial to be carried out in subjects with congenital fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia. This clinical trial is planned to be performed at study sites in multiple countries. It is planned to include a maximum of 32 adult and pediatric subjects with congenital fibrinogen deficiency in order to provide at least 28 evaluable acute bleeding episodes and/or surgical procedures.

Timeline

Start

2023-12

Primary completion

2025-03

Completion

2025-03

Drugs

Indications