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A Study of KW-3357 in Congenital Antithrombin Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00938288
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : June 17, 2011
Information provided by:
Kyowa Kirin Pharmaceutical Development, Inc.

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.

Condition or disease Intervention/treatment Phase
Congenital Antithrombin Deficiency Drug: KW-3357 Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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.
Study Start Date : April 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Single group
Drug: KW-3357
50IU/mL, IV single dose

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00938288

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Further details on request, France
Further details on request, Germany
Further details on request, Italy
Further details on request, Sweden
United Kingdom
Further details on request, United Kingdom
Sponsors and Collaborators
Kyowa Hakko Kirin UK, Ltd.
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Principal Investigator: Beverley Hunt, FRCP, FRCPath MD St Thomas' Hospital, London, UK

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Responsible Party: 3357-EU-001 Project Manager, Kyowa Hakko Kirin UK Ltd Identifier: NCT00938288     History of Changes
Other Study ID Numbers: 3357-EU-001
EudraCT number 2008-005504-16
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: March 2011

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
Hereditary Antithrombin Deficiency
Congenital Antithrombin Deficiency

Additional relevant MeSH terms:
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Antithrombin III Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Genetic Diseases, Inborn
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action