Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen

PHASE3CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 20, 2013

Primary Completion Date

November 11, 2014

Study Completion Date

November 11, 2014

Conditions
Hemophilia AHemophilia B
Interventions
BIOLOGICAL

Recombinant Factor VIIa BI (rFVIIa BI)

Administered approximately every 3 hours as an intravenous bolus injection on-demand

BIOLOGICAL

Recombinant Factor VIIa BI (rFVIIa BI)

Administered as a single intravenous bolus injection on-demand

Trial Locations (16)

11000

Clinic for Hematology of the Clinical Center of Serbia, Belgrade

11490

Tri-Service General Hospital (TSGH), Taipei

15006

Hospital Teresa Herrera Materno Infantil del C.H.U.Carretera del Pasajes/nlaboratorio de hematología, A Coruña

33607

"Health Point Medical Group St Joseph's Children's Hospital", Tampa

41013

University Hospital Virgen del Rocio, Seville

79044

Kyiv City Clinical Hospital #9, City Scientific-Practical Center for Diagnostics and Treatment of Patients with Hemostatic Pathlogies, Kiev

83045

V.K. Gusak Institute of Urgent and Reconstructive Surgery within the Ukrainian National Academy of Medical Sciences, Hematology Department, Donetsk

125167

Hematology Research Center under RAMS (State Institution), Department of Reconstructive Orthopedic Surgery for Hemophilia Patients, Moscow

195213

St. Petersburg City Healthcare Institution Municipal Policlinic # 37, Saint Petersburg

300011

Louis Turcanu Emergency Clinical Children´s Hospital, Timișoara

610027

Kirov Hematology and Blood Transfusion Research Institute under the Federal Medical and Biological Agency of Russia, Kirov

1600023

Tokyo Medical University Hospital, Tokyo

6348522

Nara Medical University Hospital, Nara

31-501

Kracow Medical Center, LLC, Krakow

02-776

Institute of Haematology and Transfusion Medicine, Clinic of Haemostatic Disorders and Internal Diseases, Warsaw

Unknown

"State Institution Institute of Blood Pathology and Transfusion Medicine within the Ukrainian National Academy of Medical Sciences, Hematology Department", Lviv

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT01757405 - Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen | Biotech Hunter | Biotech Hunter