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Sponsored by: |
Kyowa Hakko Kirin UK, Ltd. |
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Information provided by: | Kyowa Hakko Kirin Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00938288 |
The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.
Condition | Intervention | Phase |
---|---|---|
Congenital Antithrombin Deficiency |
Drug: KW-3357 |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase I Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of a Single Dose (50IU/kg) of KW-3357 in Subjects With Congenital Antithrombin Deficiency. |
Estimated Enrollment: | 16 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Single group
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Drug: KW-3357
50IU/mL, IV single dose
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Project Manager | 44(0)1753566000 | R&Dinfo@kyowa-kirin.co.uk |
Contact: Head of Clinical Development R&D | 44(0)1753566000 | R&Dinfo@kyowa-kirin.co.uk |
France | |
Not yet recruiting | |
Further details on request, France | |
Germany | |
Not yet recruiting | |
Further details on request, Germany | |
Italy | |
Not yet recruiting | |
Further details on request, Italy | |
Sweden | |
Recruiting | |
Further details on request, Sweden | |
United Kingdom | |
Recruiting | |
Further details on request, United Kingdom |
Principal Investigator: | Beverley Hunt, FRCP, FRCPath MD | St Thomas' Hospital, London, UK |
Responsible Party: | Kyowa Hakko Kirin UK Ltd ( 3357-EU-001 Project Manager ) |
Study ID Numbers: | 3357-EU-001, EudraCT number 2008-005504-16 |
Study First Received: | July 10, 2009 |
Last Updated: | July 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00938288 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Germany: Paul-Ehrlich-Institut; Sweden: Medical Products Agency |
Antithrombin Thrombosis Pharmacokinetics Hereditary Antithrombin Deficiency Congenital Antithrombin Deficiency |
Serine Proteinase Inhibitors Anticoagulants Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Thrombophilia Hemostatic Disorders |
Thrombosis Protease Inhibitors Antithrombin III Deficiency Genetic Diseases, Inborn Antithrombin III Serine |
Serine Proteinase Inhibitors Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Thrombophilia Hematologic Agents |
Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors Antithrombin III Deficiency Blood Coagulation Disorders, Inherited Genetic Diseases, Inborn Therapeutic Uses Antithrombin III |