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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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subject with development of inhibitors
Secondary outcome measures
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%
Haemorrhage intracranial
1%
Haematemesis
1%
Haemorrhage
1%
Nausea
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A
2013. "Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01619046.
All > Hemophilia A > Hemophilia
~10 spots leftby May 2025
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