Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 22, 2016

Primary Completion Date

November 11, 2019

Study Completion Date

November 11, 2019

Conditions
Congenital Afibrinogenemia
Interventions
BIOLOGICAL

Human Plasma-Derived Fibrinogen Concentrate

A sterile freeze-dried fibrinogen concentrate filled in vials containing 1 g of FIB Grifols. FIB Grifols contains 20 mg/ml of active substance fibrinogen when reconstituted.

Trial Locations (6)

11040

Northshore Long Island Jewish Medical Center, New Hyde Park

50134

Agenzia per l'Emofilia Centro di Riferimento Regionale per le Coaugulopatie Congenite A.O. di Carreggi, Florence

Unknown

S.S. Institute of Medical Sciences and Research Centre, Davangere

St. Johns Medical College and Hospital, Bangalore

Sahyadri Specialty Hospital, Pune

Hôtel-Dieu de France Hospital, Beirut

Sponsors
All Listed Sponsors
collaborator

Instituto Grifols, S.A.

INDUSTRY

lead

Grifols Therapeutics LLC

INDUSTRY