GreenGeneTM F_P3 (A study in patients with severe Haemophilia A)
Research type
Research Study
Full title
Determination of Safety, Efficacy, and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 years of age or older Diagnosed with Severe Hemophilia A
IRAS ID
107561
Contact name
Paul Giangrande
Sponsor organisation
Green Cross Corporation
Eudract number
2012-001445-40
Clinicaltrials.gov Identifier
Research summary
This is an open-label, multi-centre, prospective, non-randomised, non-controlled study to assess the safety, efficacy and pharmacokinetics of GreenGene?½ F in patients with severe Haemophilia A. It will be tested on previously treated patients (>150 exposure days) with a Factor VIII concentrate and without presence of history of inhibitors to FVIII (Factor VIII). Patients aged 12 years of age and over will be recruited into this study. The objective of the study is to demonstrate the safety of GreenGene?½ F with respect to inhibitor development (neutralizing anti-Factor VIII antibodies) over a minimum of 50 exposure days (primary objective); and to assess the long-term (50 exposure days) safety of GreenGene?½ F. Other objectives of the study are to demonstrate efficacy and pharmacokinetics of the GreenGene?½ F study medication. This study is expected to be completed within 12 months. Patients treated by prophylaxis and on demand are expected to complete and exit the study after 50 exposure days. The study will be completed 24-48 months after the enrolment of the first subject. Final inhibitor evaluation will be assessed after 50 exposure days. There is also an optional PK study associated, in which patients are asked if they would be willing to participate. If they wish to do so they will complete this prior to starting their 50 exposure period to GreenGene?½ F.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
12/SC/0579
Date of REC Opinion
9 Jan 2013
REC opinion
Further Information Favourable Opinion