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A Study of KW-3357 in Congenital Antithrombin Deficiency
This study is currently recruiting participants.
Verified by Kyowa Hakko Kirin Pharma, Inc., July 2009
First Received: July 10, 2009   No Changes Posted
Sponsored by: Kyowa Hakko Kirin UK, Ltd.
Information provided by: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00938288
  Purpose

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.

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:
  • To evaluate the pharmacokinetic profile of a single dose (50 IU/kg) of KW 3357 in subjects with congenital AT deficiency [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety and tolerability of a single dose (50 IU/kg) of KW-3357 in subjects with congenital AT deficiency [ Designated as safety issue: Yes ]

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
Drug: KW-3357
50IU/mL, IV single dose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938288

Contacts
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

Locations
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
Sponsors and Collaborators
Kyowa Hakko Kirin UK, Ltd.
Investigators
Principal Investigator: Beverley Hunt, FRCP, FRCPath MD St Thomas' Hospital, London, UK
  More Information

No publications provided

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

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
Antithrombin
Thrombosis
Pharmacokinetics
Hereditary Antithrombin Deficiency
Congenital Antithrombin Deficiency

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009