19580 aTFPI
Research type
Research Study
Full title
Multiple escalating dose study of BAY 1093884 in adults with Haemophilia A or B with or without inhibitors.
IRAS ID
240062
Contact name
Charles Hay
Contact email
Sponsor organisation
Bayer AG
Eudract number
2017-003324-67
Duration of Study in the UK
1 years, 7 months, 12 days
Research summary
This is an open-label, phase 2 study with multiple escalating subcutaneous doses of BAY 1093884 in adults (age≥ 18 years) with Haemophilia A or B with or without inhibitors.
The primary objective is to evaluate the safety and tolerability of BAY 1093884.
Exploratory objectives: pharmacokinetics (PK) and pharmacodynamics (PD) of BAY 1093884 and the effect of different doses of BAY 1093884 in bleeding control.
Major Inclusion criteria:
• Male subjects with Haemophilia A or Haemophilia B (any severity) with inhibitors against FVIII or FIX (any inhibitor titer).
• Male subjects with severe Haemophilia A (FVIII activity <1%) or B (FIX activity <2%) without inhibitors.
• Subjects with a past history of inhibitors (any inhibitor titer) are eligible.Major exclusion criteria
• History of any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/FV deficiency) or platelet disorder.
• History of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, and thrombophlebitis) or thrombotic microangiopathy.
• Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes).
• History of cardiac, coronary and/or arterial peripheral atherosclerotic disease, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris or treatment for angina pectoris.REC name
London - Central Research Ethics Committee
REC reference
18/LO/0656
Date of REC Opinion
22 Jun 2018
REC opinion
Further Information Favourable Opinion