Phase 1, FIM study of BAY 1093884 in Subjects with Heamophilia A or B
Research type
Research Study
Full title
A Phase 1, first in man, multicenter, open label, single escalating dose study of BAY 1093884 in subjects with severe Hemophilia types A or B, with or without inhibitors
IRAS ID
168973
Contact name
Charles Hay
Contact email
Sponsor organisation
Bayer AG
Eudract number
2014-003283-20
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
This is an open label, first in man, multicenter, single escalating dose study to evaluate the safety, tolerability, pharmacokinetics (PK, the way the body absorbs, distributes and gets rid of a drug) and pharmacodynamics (the study of how a drug acts on in the body) of BAY 1093884 in patients with severe Haemophilia A or B with or without inhibitors.
Haemophilia is a hereditary coagulation disorder caused by a shortage of Factor VIII (FVIII, Haemophilia A) or Factor IX (FIX, Haemophilia B). The standard treatment for Haemophilia A or B is IV replacement therapy, with plasma-derived or recombinant FVIII or FIX respectively. However, the body’s immune system can produce antibodies against these factors (‘inhibitors’) which can reduce the efficacy of this treatment and make bleeds very difficult to control.The total duration of the study will be about 25 months. The study involves 9 or 10 visits and participation is expected to last no more than 3.5 months.
Approximately 22 male patients with severe Haemophilia A or B aged 18 to 65 years will take part in 3 countries.
After obtaining informed consent and performance of screening procedures, patients who meet all inclusion and exclusion criteria will be administrated study drug. Drug will be administered via IV infusion over 1 hour.
BAY 1093884 is being developed by Bayer HealthCare AG. This is the first study to determine whether the treatment is safe at different dose levels and also to determine the dose at which BAY 1093884 may be sufficient to have a positive effect on participants with severe haemophilia.
REC name
West of Scotland REC 1
REC reference
15/WS/0128
Date of REC Opinion
16 Sep 2015
REC opinion
Further Information Favourable Opinion