Adjusted Fibrinogen Replacement Strategy

PHASE3CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

April 3, 2018

Primary Completion Date

September 25, 2023

Study Completion Date

November 21, 2023

Conditions
Bleeding DisorderHypofibrinogenemia; Acquired
Interventions
BIOLOGICAL

BT524

BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.

BIOLOGICAL

FFP/Cryo

FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryoprecipitate, fixed dose of 10 units.

Trial Locations (19)

Unknown

Site 02, Jette

Site 01, Leuven

Site 54, Brno

Site 51, Prague

Site 53, Prague

Site 52, Ústí nad Labem

Site 15, Bielefeld

Site 11, Bonn

Site 12, Hanover

Site 14, München

Site 13, Münster

Site 21, Warsaw

Site 31, Barcelona

Site 32, Barcelona

Site 33, Barcelona

Site34, Barcelona

Site 41, Liestal

Site 43, Zurich

Site 71, Basingstoke

Sponsors
All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

collaborator

ICON Clinical Research

INDUSTRY

lead

Biotest

INDUSTRY