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Recombinant Factor VIII

Surgical substudy for 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

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).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evert 3 months, up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and evert 3 months, up to 18 months for reporting.

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

Side effects data

From 2015 Phase 4 trial • 303 Patients • NCT01064284
17%
Pyrexia
12%
Nasopharyngitis
8%
Cough
8%
Upper respiratory tract infection
6%
Viral infection
6%
Vomiting
5%
Diarrhoea
5%
Bronchitis
3%
Anaemia
2%
Head Injury
2%
Subcutaneous haematoma
2%
Pharyngitis
1%
Haematemesis
1%
Haemorrhage
1%
Nausea
1%
Haemorrhage intracranial
1%
Haemorrhagic anaemia
1%
Hemiparesis
1%
Hemiplegia
1%
Hypersomnia
1%
Lymphadenopathy
1%
Pancytopenia
1%
Road traffic accident
1%
Seizure
1%
Skin haemorrhage
1%
Speech disorder developmental
1%
Urinary tract infection
1%
Vessel puncture site haemorrhage
1%
Haemarthrosis
1%
Muscle haemorrhage
1%
Subdural haematoma
1%
Abdominal wall haemorrhage
1%
Cerebral haemorrhage
1%
Circumcision
1%
Epidural Haemorrage
100%
80%
60%
40%
20%
0%
Study treatment Arm
pd vWF/FVIII
rFVIII

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).

Find a Location

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
~10 spots leftby Sep 2025
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