Haemophilia A MedDRA version: 14.1 Level: LLT Classification code 10018937 Term: Haemophilia A System Organ Class: 100000004850
Conditions
Sponsors
Green Cross Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female subjects age = 12 years at time of informed consent 2.Body weight = 35 kg 3.Diagnosed with severe hemophilia A. Subjects must have severe hemophilia A with baseline FVIII =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1.Presence at Screening of FVIII inhibitor = 0.6 BU as tested with the Nijmegen modification of the Bethesda assay in either central or local laboratory 2.History of FVIII inhibitor of = 0.6 BU as measured using the Nijmegen modification of the Bethesda assay 3.History of FVIII inhibitor = 1.0 BU if the subject has been tested routinely using the original Bethesda assay, or history of periods with low recovery and no response to Factor VIII treatment 4.Demonstrated an inability to respond to conventional doses of FVIII therapy 5.History of incremental recovery of Factor VIII 1.4, the presence of splenomegaly and/or spider angiomata on physical examination and/or a history of esophageal hemorrhage or documented esophageal varices 8.Uncontrolled hypertension (diastolic blood pressure >100 mm Hg) 9.Hemoglobin 2x upper limit of normal [ULN], total bilirubin > 2x the ULN) 13.Liver disease (alanine aminotransferase [ALT], aspartate aminotransferase [ AST] > 3x the ULN) 14.History of diabetes or other metabolic disease 15.History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrate 16.History of pretreatment prior to the administration of FVIII products (e.g., of antihistamines) 17.Regular use of antifibrinolytics or medications affecting platelet function 18.Hypersensitivity to hamster-or mouse derived proteins 19.Blood transfusions within 30 days of enrollment into the study 20.Current participation in another investigational drug or device study, or participated in a clinical study involving an investigational drug or device within 30 days of enrollment into the study 21.Unable or unwilling to cooperate with study procedures 22.Females who are pregnant (positive ß-hCG test) or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate safety of GreenGene™ F with respect to inhibitor development (neutralizing anti-Factor VIII antibodies) and long-term safety •To evaluate the hemostatic efficacy in prophylaxis (rate of breakthrough bleeding) and on demand treatment in the management of acute bleeding events; •To evaluate the physicians and subjects rating of response for on demand treatment of bleeding episodes; and •To evaluate peri-operative hemostatic control of GreenGene™ F during surgical and invasive diagnostic procedures. ;Secondary Objective: Please see main objective above.;Primary end point(s): Safety and efficacy; The primary safety objective is to demonstrate a sufficiently low incidence of inhibitor associated with the use GreenGene™ F. ;Timepoint(s) of evaluation of this end point: Safety and efficacy; Following a minimum 50 exposure days for both prophylaxis and on demand patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and efficacy; • Frequency of breakthrough bleeds (total, trauma and joint); • Subject evaluation of efficacy; • Number of infusions per bleeding episodes; • Units of FVIII per infusion per bleeding episode; • Units of FVIII per bleeding; and • Units of FVIII per prophylaxis treatment. ;Timepoint(s) of evaluation of this end point: Safety and efficacy; Following a minimum 50 exposure days for both prophylaxis and on demand patients. | — |
Countries
Canada, Croatia, New Zealand, Poland, Russian Federation, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Atlantic Research Group, Inc.
Outcome results
None listed