124
Participants
Start Date
March 31, 2013
Primary Completion Date
July 31, 2015
Study Completion Date
September 30, 2015
GreenGene™ F and an approved recombinant Factor VIII product
one 50 IU/kg, intra-venous infusion over 5 minutes, Infusion rate \< 10 mL/min
GreenGene™ F
intra-venous infusion, 30 ± 5 IU/kg infusions 3 times per week with dose escalation to 45 ± 5 IU/kg if appropriate, for 50 exposure days
GreenGene™ F
"intra-venous infusion,~On-demand safety and efficacy substudy:~minor bleed = 10-20 IU/kg moderate bleed = 15-30 IU/kg major bleed = 30-50 IU/kg"
GreenGene™ F
"intra venous infusion,~Surgical substudy:~Minor surgery including tooth extraction = Post in fusion FVIII level of 60-100% of normal. A single bolus infusion (30-50 IU/kg) beginning within one hour of the operation. Optional additional dosing every 12 to 24 hours as needed to control bleeding.~Major surgery = Pre- and post infusion FVIII level 80-120% of normal. Preoperative bolus infusion: 40-60 IU/kg. Verified 100% activity prior to surgery. Maintenance bolus infusion (40-60 IU/kg) repeat infusions every 8 to 24 hours, depending on the desired level."
RECRUITING
Research Associates, Ltd., Christchurch
RECRUITING
Long Island Jewish Medical Center - Hemophilia Treatment Center, New Hyde Park
RECRUITING
University of Miami - Comprehensive Hemophilia Center, Miami
RECRUITING
Michigan State University Center for Bleeding Disorders & Clotting Disorders, East Lansing
RECRUITING
Dnepropetrovsk City Clinical Hospital, Dnipro
RECRUITING
Rush University Medical Center, Chicago
RECRUITING
Kharkov Regional Clinical Oncology Center, Kharkiv
RECRUITING
Children's Mercy Hospital - Kansas City Regional Hemophilia Center, Kansas City
RECRUITING
Zaporizhzhya Region Clinical Child Hospital, Zaporzhye
RECRUITING
Arkansas Children's Hospital, Little Rock
RECRUITING
St. Luke's Boise Medical Center, Boise
RECRUITING
Los Angeles Orthopaedic Hospital - Hemophilia Treatment Center, Los Angeles
RECRUITING
Harbor - UCLA Pediatrics, Torrance
RECRUITING
Oregon Health and Science University, Portland
RECRUITING
Ismailov City Children's Clinical Hospital of Board of Health of Moscow City, Moscow
RECRUITING
"State Budget Educational Institution of Higher professional Education Samara State Medical University of the Ministry of Health and Social Process of the Russian Federation", Samara
RECRUITING
Ufa Republican Clinical Hospital, Ufa
RECRUITING
Kirov Research Institute of Hematology and Blood Transfusion, Kirov
RECRUITING
Barnaul Altai State Scientfic Center, Barnaul
RECRUITING
University of Alberta, Edmonton
RECRUITING
McMaster Children's Hospital, Hamilton
RECRUITING
Instytut Hematologii i Transfuzjologii, Warsaw
RECRUITING
wojewodzki szpital Specjalistyczny, klinika hematologii uniwersytetu medycznego w łodzi, Łodzi
RECRUITING
Institute of Urgent and Reconstructive surgery named after V.K. Gusak of National Academy of Medical Sciences of Ukraine, Donetsk
RECRUITING
Kyiv City Clinical Hospital No 91, Kyiv
RECRUITING
Institute of Blood Pathology and Transfusion Medicine of National Academy of Medical Sciences of Ukraine Department of Surgery and Clinical Transfusiology, Lviv
RECRUITING
Central Manchester University Hospitals, Manchester
RECRUITING
Royal Cornwall Hospital, Department of Haematology, Truro
RECRUITING
Hull Haemophillia Centre, Hull Royal Infirmary, Humberside
RECRUITING
St. Thomas' Hospital, City of Westminster
RECRUITING
North Hampshire Haemophilia Centre, Basingstoke
RECRUITING
University of Liverpool, Liverpool
RECRUITING
Royal Free Hospital, Haemophilia Centre & Thrombosis Unit, London
RECRUITING
Churchill Hospital, Oxford, Oxford
Lead Sponsor
Collaborators (1)
Atlantic Research Group
OTHER
Green Cross Corporation
INDUSTRY