A Study of KW-3357 in Congenital Antithrombin Deficiency

Congenital Antithrombin Deficiency Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938288
• Other study ID #: 3357-EU-001
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2009
• Last updated: June 15, 2011
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: March 2011
• Source: Kyowa Hakko Kirin Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthGermany: Paul-Ehrlich-InstitutSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Antithrombin III Deficiency
• Congenital Antithrombin Deficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin UK, Ltd.

Countries where clinical trial is conducted

France,  Germany,  Italy,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pharmacokinetic profile of a single dose (50 IU/kg) of KW 3357 in subjects with congenital AT deficiency		July 2011	No
Secondary	To determine the safety and tolerability of a single dose (50 IU/kg) of KW-3357 in subjects with congenital AT deficiency		July 2011	Yes