The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.
Patients with Congenital Antithrombin Deficiency are at increased risk of venous thrombosis and pulmonary embolism especially when undergoing certain high risk procedures. Antithrombin replacement therapy is often administered during these periods, with or without low molecular weight heparin. Prior to assessing the efficacy of KW-3357, a new recombinant human antithrombin, the present study will determine it's pharmacokinetics, safety and tolerability in subjects who have Congenital Antithrombin Deficiency but who are currently asymptomatic and not undergoing a high-risk procedure. Up to 16 evaluable subjects will be enrolled at multiple investigational sites over a period of approximately 7 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
50IU/mL, IV single dose
Department of Haemotogy, Haemastasy, Oncology and Stem Cell Transplantation, Hannover Medical School
Hanover, Germany
Center for Thrombosis and Haemostasis, Malmo University Hospital
Malmo, Sweden
Dept Obst Gyn/Section for Women and Child Health/Clinical Trial Unit, Karolinska University Hospital
Stockholm, Sweden
To evaluate the pharmacokinetic profile of a single dose (50 IU/kg) of KW 3357 in subjects with congenital AT deficiency
Time frame: July 2011
To determine the safety and tolerability of a single dose (50 IU/kg) of KW-3357 in subjects with congenital AT deficiency
Time frame: July 2011
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Treliske, Haematology Clinic, Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Bristol Haemophia Care Centre, Bristol Haemotology and Oncology Centre
Bristol, United Kingdom
Department of Haemotology, Glasgow Royal Infirmary
Glasgow, United Kingdom
Kings College, Dept of Haematology, Lupus & Pathology Guy's and St Thomas Trust, St Thomas Hospital, Ctr for Haemostasis and Thrombosis (the Haemophia Reference Ctr)
London, United Kingdom
University College London Hospital NHS Trust
London, United Kingdom