Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors

PHASE3CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

August 31, 2015

Conditions
Hemophilia A With InhibitorsHemophilia B With Inhibitors
Interventions
BIOLOGICAL

Coagulation Factor VIIa (Recombinant)

A cross over design to assess the efficacy of 2 separate dose regimens (75µg/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/IX

Trial Locations (17)

5261

Chaim Sheba Medical Center, Tel-hashomer hospital, Ramat Gan

55455

University of Minnesota Medical Center Fairview, Minneapolis

60612

Rush University Medical Center, Chicago

80045

University of Colorado Hemophilia and Thrombosis Center, Aurora

90007

Orthopaedic Hemophilia Treatment Center, Los Angeles

95817

University of California Davis Comprehensive Cancer Center, Sacramento

Unknown

Republican Research Center for Radiation Medicine and Human Ecology, Homyel

Specialized Hospital for Active Treatment of Hematological Diseases, Sofia

LTD HEMA, Tbilisi

Institute of Hematology and Transfusion Medicine, Warsaw

Sandor SRL, Bucharest

Kirov Research Institute of Hematology and Blood Transfusion, Kirov

Hematology Research Center, Moscow

City Outpatient Clinic #37, Saint Petersburg

Kyiv City Clinical Hospital #9, Kyiv

Institute of Blood Pathology and Transfusion Medicine of Academy of Medical Sciences of Ukraine, Lviv

Basingstoke and North Hampshire Hospital, Hemophilia, Hemostasis and Thrombosis Center, Basingstoke

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

lead

rEVO Biologics

INDUSTRY

NCT02020369 - Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors | Biotech Hunter | Biotech Hunter