← 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

Study 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 weeks
Treatment ~ Varies
Follow Up ~every 3 months, up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 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 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
23,893 Total Patients Enrolled
3 Trials studying Hemophilia A
236 Patients Enrolled for Hemophilia A

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 and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A
2014. "Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02027779.
All > Hemophilia A > Hemophilia
~13 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top