Revo Phase 3: Coagulation Factor VIIa in Congenital Hemophilia A or B
Research type
Research Study
Full title
A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients with Inhibitors to Factor VIII or IX
IRAS ID
151104
Contact name
Savita Rangarajan
Contact email
Sponsor organisation
rEVO Biologics, Inc.
Eudract number
2013-004779-11
Clinicaltrials.gov Identifier
Research summary
This is a global, multi-center, Phase III, Prospective, Open-label, Randomized, Cross Over Study designed to evaluate the efficacy, safety and behaviour in human blood of LR769 in patients with Hemophilia A or B with inhibitors to factor VII or IX.
Hemophilia is a hereditary coagulation disorder caused by a shortage of factor VIII (Hemophilia A) or factor IX (Hemophilia B). Hemophilia is usually treated with factor VII (FVIII) or factor IX (FIX) concentrate. However, the body's immune system can produce antibodies against these factors ('inhibitors) which can reduce the efficacy of this treatment.
This research study will involve about 25 male patients between the ages of 12 and 75 years old at about 25 centres worldwide. The overall duration of the study is approximately 16 months. The duration of each patient's participation in the study may vary from approximately 7 months to approximately 16 months depending on when the patient was enrolled, unless discontinued prematurely.
after obtaining informed consent and performance of screening procedures, patients who meet all inclusion and exclusion criteria will be randomised to start with one of two treatment regimens (75 or 225). The assigned treatment regime is the does administered in Phase A and the starting dose in Phase B. The dose of the study drug will be switched every 3 months until the end of the study.
LR 769 is a Coagulation Factor VIIA (recombinant) being developed by rEVO Biologics Inc.REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0269
Date of REC Opinion
3 Jul 2014
REC opinion
Further Information Favourable Opinion