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Recombinant Factor VIII
Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A
Phase 3
Waitlist Available
Led By Paul LeoFrancis Giangrande, MD
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 evert 3 months, up to 18 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Summary
The purpose of this study is to assess the safety, efficacy and pharmacokinetics of GreenGene™ F in subjects with severe hemophilia A previously treated (\> 150 exposure days) with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (Factor VIII).
Eligible Conditions
- Hemophilia A
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evert 3 months, up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evert 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 subject with development of inhibitors
Secondary study objectives
Describe the PK profile of GreenGene™ F
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Surgical substudyExperimental Treatment1 Intervention
Peri-operative hemostatic control of GreenGene™ F in surgery or invasive procedures will be assessed in at least 10 surgeries, some of them major, in at least five subjects
Group II: 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 exposure days.
Group III: 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 50 exposure days.
Group IV: PK substudyActive Control1 Intervention
A cohort of 13-18 subjects will be included in the pharmacokinetic (PK) evaluation of GreenGene™ F and an approved recombinant Factor VIII product (Refacto AF); a minimum of 13 of these subjects will be re-evaluated at study end (50 exposure day).
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Who is running the clinical trial?
Green Cross CorporationLead Sponsor
81 Previous Clinical Trials
23,917 Total Patients Enrolled
3 Trials studying Hemophilia A
262 Patients Enrolled for Hemophilia A
Atlantic Research GroupOTHER
8 Previous Clinical Trials
471 Total Patients Enrolled
1 Trials studying Hemophilia A
150 Patients Enrolled for Hemophilia A
Paul LeoFrancis Giangrande, MDPrincipal InvestigatorOxford Haemophilic Centre and Thrombosis Unit, Churchill Hospital