Brief Title
Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A
Official Title
An Open Label Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A
Brief Summary
This study primarily will address the safety and secondarily will assess efficacy of
GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a
GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of subjects with development of inhibitors
Condition
Hemophilia A
Intervention
GreenGene™ F
Study Arms / Comparison Groups
Prophylaxis safety and efficacy substudy
Description: Hemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding during prophylaxis over ≥ 50 additional exposure days.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
150
Start Date
January 2014
Completion Date
February 2016
Primary Completion Date
December 2015
Eligibility 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 (<0.6BU Nijmegen assay), i.e. at the
end of study "GreenGene™ F_P3" for patients entering into this extension study
immediately after finishing the previous phase III study.
4. Normal liver and kidney function
5. Platelet count ≥ 100,000㎕
6. Normal prothrombin time or International Normalized Ratio (INR) < 1.5
7. Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be
on a stable treatment regimen
8. Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each
inhibitor assay
9. Absolute CD4 lymphocyte cell count ≥ 200㎕
10. Signed the written informed consent form or informed consent was obtained from the
subject's legal guardian
11. Females must not be lactating or pregnant at screening or Baseline (as documented by a
negative beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of
25 IU/L or equivalent units of β-hCG). A test was obtained more than 72 hours before
the first dose of study drug
12. All females will be considered to be of childbearing potential unless they are
appropriate age group and without other known or suspected cause) or have been
sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy or bilateral
oophorectomy, all with surgery at least one month before dosing)
13. Willing and able to comply with all aspects of the protocol
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 < 10 g/dL
5. Severe renal dysfunction (creatinine > 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 β-hCG test) or breastfeeding
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, +82 31 260 9729, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02027779
Organization ID
GreenGene™ F_E_P3
Responsible Party
Sponsor
Study Sponsor
Green Cross Corporation
Collaborators
Atlantic Research Group
Study Sponsor
, ,
Verification Date
January 2014