Status:
COMPLETED
A Study of KW-3357 in Congenital Antithrombin Deficiency
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Kyowa Hakko Kirin UK, Ltd.
Conditions:
Congenital Antithrombin Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.
Detailed Description
Patients with Congenital Antithrombin Deficiency are at increased risk of venous thrombosis and pulmonary embolism especially when undergoing certain high risk procedures. Antithrombin replacement the...
Eligibility Criteria
Inclusion
- Male or female subjects at least 18 years of age with congenital Antithrombin deficiency (AT activity ≤60% of normal) in a stable condition without evidence of acute thromboembolic events
- Signed IEC-approved Informed Consent Form
- Subjects must not have received an infusion of Antithrombin for at least 14 days before Screening
- Patients of reproductive potential must agree to follow accepted birth control methods during the study
Exclusion
- Subjects who are classified as morbidly obese (defined by the presence of a body mass index \>40 kg/m2)
- Subjects who have participated in a study with an investigational drug within 30 days of Screening or within 5.5 times the elimination half-life of the investigational drug before Screening, whichever period is greater
- Subjects with any clinically relevant medical history or current condition or physical findings, ECG, or laboratory values which could interfere with the objectives of the study or the safety of the subject
- Subjects using non-steroidal anti-inflammatories, fondaparinux sodium, dabigatran or rivaroxaban or who are expected to be treated with these drugs during the study
- Subjects who have concomitant nephrotic syndrome
- Female subjects who are pregnant or lactating
- Subjects who are taking heparin, low molecular weight heparin and/or oral anticoagulants, with the exception of vitamin K antagonists (eg, warfarin)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00938288
Start Date
April 1 2009
End Date
April 1 2011
Last Update
October 17 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Haemotogy, Haemastasy, Oncology and Stem Cell Transplantation, Hannover Medical School
Hanover, Germany, 30625
2
Center for Thrombosis and Haemostasis, Malmo University Hospital
Malmo, Sweden, SE-205 02
3
Dept Obst Gyn/Section for Women and Child Health/Clinical Trial Unit, Karolinska University Hospital
Stockholm, Sweden, SE-171 76
4
Treliske, Haematology Clinic, Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3LJ