A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa

PHASE3CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 7, 2015

Primary Completion Date

June 30, 2017

Study Completion Date

August 30, 2017

Conditions
Hemophilia A With InhibitorsHemophilia B With Inhibitors
Interventions
BIOLOGICAL

Coagulation FVIIa (Recombinant)

A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX

Trial Locations (9)

73117

Jimmy Everest Center for Cancer and Bleeding Disorders, Oklahoma City

75390

UT Southwestern Medical Center at Dallas / Children's Medical Center, Dallas

80045

University of Colorado Denver Hemophilia & Thrombosis Center, Aurora

Unknown

"University Multiprofile Hospital for Active Treatment Sveti Georgi", Plovdiv

University Hospital Motol, Prague

Hematology of Department Hemophilia and Thromboses center, Tbilisi

Worthwhile Clinical Trials, Benoni

National Specialized Children's Hospital OKHMATDYT, Centre for Hemostatic Pathology (Ukraine), Kyiv

Institute of Blood Pathology and Transfusion Medicine, Lviv

All Listed Sponsors
collaborator

LFB USA, Inc.

INDUSTRY

lead

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

NCT02448680 - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa | Biotech Hunter | Biotech Hunter