Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A
An Open Label Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A
1 other identifier
interventional
150
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 2, 2014
CompletedFirst Posted
Study publicly available on registry
January 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJanuary 6, 2014
January 1, 2014
1.9 years
January 2, 2014
January 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with development of inhibitors
Development of neutralizing antibodies (inhibitors) will be followed during the regular visits, average of 3 months.
every 3 months, up to 18 months
Study Arms (2)
Prophylaxis safety and efficacy substudy
EXPERIMENTALHemostatic 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.
On-demand safety and efficacy substudy
EXPERIMENTALHemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding in a minimum of 10 on demand treated subjects during additional 50 exposure days.
Interventions
Prophylaxis safety and efficacy substudy: intra venous infusion, 30 ± 10 IU/kg infusions 3 times per week with dose escalation to 45 ± 10 IU/kg if appropriate, for 50 exposure days
Eligibility Criteria
You may qualify if:
- Subjects must have participated in the "GreenGene™ F\_P3", (with Eudra CT number 2012-001445-40) or a pediatric study with GreenGene™ F
- Have ≥50 previous exposure days to GreenGene™ F, as documented in the subject's medical records.
- Normal liver and kidney function
- Platelet count ≥ 100,000㎕
- Normal prothrombin time or International Normalized Ratio (INR) \< 1.5
- Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be on a stable treatment regimen
- Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each inhibitor assay
- Absolute CD4 lymphocyte cell count ≥ 200㎕
- Signed the written informed consent form or informed consent was obtained from the subject's legal guardian
- 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
- 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)
- Willing and able to comply with all aspects of the protocol
You may not qualify if:
- Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen modification of the Bethesda assay.
- 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
- Uncontrolled hypertension (diastolic blood pressure \>100 mm Hg)
- Hemoglobin \< 10 g/dL
- Severe renal dysfunction (creatinine \> 2x upper limit of normal \[ULN\], total bilirubin \> 2x the ULN)
- Liver disease (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] \> 3x the ULN)
- History of diabetes or other metabolic disease
- History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrates
- History of pretreatment prior to the administration of FVIII products (e.g., antihistamines)
- Regular use of antifibrinolytics or medications affecting platelet function
- Hypersensitivity to hamster- or mouse derived proteins
- Blood transfusions within 30 days of enrollment into the study
- 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
- Unable or unwilling to cooperate with study procedures
- Females who are pregnant (positive β-hCG test) or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Green Cross Corporationlead
- Atlantic Research Groupcollaborator
Study Sites (2)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Long Island Jewish Medical Center - Hemophilia Treatment Center
New Hyde Park, New York, 11040, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2014
First Posted
January 6, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
January 6, 2014
Record last verified: 2014-01