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A Study of KW-3357 in Congenital Antithrombin Deficiency

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00938288
First received: July 10, 2009
Last updated: June 15, 2011
Last verified: March 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

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 [ Time Frame: July 2011 ] [ 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 [ Time Frame: July 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: April 2009
Study Completion Date: April 2011
Primary Completion Date: December 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

Locations
France
Further details on request, France
Germany
Further details on request, Germany
Italy
Further details on request, Italy
Sweden
Further details on request, Sweden
United Kingdom
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: 3357-EU-001 Project Manager, Kyowa Hakko Kirin UK Ltd
ClinicalTrials.gov Identifier: NCT00938288     History of Changes
Other Study ID Numbers: 3357-EU-001, EudraCT number 2008-005504-16
Study First Received: July 10, 2009
Last Updated: June 15, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Antithrombin III Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Thrombophilia
Genetic Diseases, Inborn
Antithrombins
Antithrombin III
 Antithrombin Proteins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013