A Safety and Efficacy study of GreenGene™ F in Patients Diagnosed with Severe Hemophilia A who have previously completed another study with GreenGene™ F

Registry ID

EUCTR2013-004383-62

Source registry

EUCTR

Status

Prematurely Ended

Phase

PHASE3

Sponsor

Green Cross Corporation

Start date

2013-12-12

Completion date

2015-01-20

Last update

2026-08-16

Conditions

• Haemophilia A

Summary

Safety Objectives: •To demonstrate safety of GreenGene™ F with respect to inhibitor development (neutralizing anti-Factor VIII antibodies) over a minimum of additional 50 exposure days (primary objective) •To assess the long-term (additional 50 exposure days) safety of GreenGene™ F. Efficacy Objectives: •To evaluate the hemostatic efficacy of GreenGene™ F in prophylaxis (rate of breakthrough bleeding) and on demand treatment in the management of acute bleeding events •To evaluate the physicians and subjects rating of response for on demand treatment of bleeding episodes

Locations

• , , UK

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