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.Subjects must have participated in the “GreenGene™ F_P3”, (with Eudra CT number 2012-001445-40) or a pediatric study with GreenGene™ F 2.Have = 50 previous exposure days to GreenGene™ F, as documented in the subject’s medical records. 3.Negative assays for FVIII inhibitor at inclusion (=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.Presence at Screening of FVIII inhibitor = 0.6 BU as tested with the Nijmegen modification of the Bethesda assay. 2.Laboratory or clinical evidence of portal vein hypertension including, but not limited to, an INR > 1.4, the presence of splenomegaly and/or spider angiomata of physical examination and/or a history of esophageal hemorrhage or documented esophageal varices 3.Uncontrolled hypertension (diastolic blood pressure >100 mm Hg) 4.Hemoglobin 2x upper limit of normal [ULN], total bilirubin > 2x the ULN) 6.Liver disease (alanine aminotransferase [ALT], aspartate aminotransferase [AST] > 3x the ULN) 7.History of diabetes or other metabolic disease 8.History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrates 9.History of pretreatment prior to the administration of FVIII products (e.g., antihistamines) 10.Regular use of antifibrinolytics or medications affecting platelet function 11.Hypersensitivity to hamster-or mouse derived proteins 12.Blood transfusions within 30 days of enrollment into the study 13.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 14.Unable or unwilling to cooperate with study procedures 15.Females who are pregnant (positive ß-hCG test) or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Objectives: •To demonstrate safety of GreenGene™ F with respect to inhibitor development (neutralizing anti-Factor VIII antibodies) over a minimum of additional 50 exposure days (primary objective) •To assess the long-term (additional 50 exposure days) safety of GreenGene™ F. Efficacy Objectives: •To evaluate the hemostatic efficacy of GreenGene™ F 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 ;Secondary Objective: Not applicable;Primary end point(s): Efficacy endpoints for this study include: •The consumption of Factor VIII, expressed as number of infusions and IU/kg per month and per year, as well as •IU/kg per event (prophylaxis, on-demand, and surgery). •Frequency of breakthrough bleedings; •Physicians and subject evaluation of efficacy (on-demand and surgery); •Number of infusions of study drug per bleeding episode •Unit of FVIII per treatment (prophylaxis) Safety endpoints: All safety analyses will be summarized and presented for the Safety Analysis Set. The safety of GreenGene™ F will be assessed by monitoring the rate of inhibitor incidence, adverse effects and changes in clinical laboratory parameters;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): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Canada, Croatia, European Union, Hungary, Moldova, Republic of, New Zealand, Poland, Romania, Russian Federation, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Atlantic Research Group, Inc
Outcome results
None listed