Your session is about to expire
← Back to Search
Recombinant Factor VIII
On-demand safety and efficacy substudy for Hemophilia A
Phase 3
Waitlist Available
Research Sponsored by Green Cross Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months, up to 18 months
Awards & highlights
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).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months, up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months, up to 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of subjects with development of inhibitors
Trial Design
2Treatment groups
Experimental Treatment
Group I: Prophylaxis safety and efficacy substudyExperimental Treatment1 Intervention
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.
Group II: On-demand safety and efficacy substudyExperimental Treatment1 Intervention
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 in a minimum of 10 on demand treated subjects during additional 50 exposure days.
Find a Location
Who is running the clinical trial?
Atlantic Research GroupOTHER
8 Previous Clinical Trials
445 Total Patients Enrolled
1 Trials studying Hemophilia A
124 Patients Enrolled for Hemophilia A
Green Cross CorporationLead Sponsor
81 Previous Clinical Trials
23,891 Total Patients Enrolled
3 Trials studying Hemophilia A
236 Patients Enrolled for Hemophilia A
Share this study with friends
Copy Link
Messenger