Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 10, 2009
June 15, 2011
April 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00938288 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
A Study of KW-3357 in Congenital Antithrombin Deficiency
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.

The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Congenital Antithrombin Deficiency
Drug: KW-3357
50IU/mL, IV single dose
1
Single group
Intervention: Drug: KW-3357
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
April 2011
December 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Sweden,   United Kingdom
 
NCT00938288
3357-EU-001, EudraCT number 2008-005504-16
No
3357-EU-001 Project Manager, Kyowa Hakko Kirin UK Ltd
Kyowa Hakko Kirin UK, Ltd.
Not Provided
Principal Investigator: Beverley Hunt, FRCP, FRCPath MD St Thomas' Hospital, London, UK
Kyowa Hakko Kirin Pharma, Inc.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP