Clinical trial NCT00938288: A Study of KW-3357 in Congenital Antithrombin Deficiency
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Antithrombin Deficiency
Keywords: Antithrombin
Thrombosis
Pharmacokinetics
Hereditary Antithrombin Deficiency
Congenital Antithrombin Deficiency
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Hakko Kirin UK, Ltd.
First posted: 2009-07-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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 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)

Primary outcomes:
measure: To evaluate the pharmacokinetic profile of a single dose (50 IU/kg) of KW 3357 in subjects with congenital AT deficiency
timeFrame: July 2011
Secondary outcomes:
measure: To determine the safety and tolerability of a single dose (50 IU/kg) of KW-3357 in subjects with congenital AT deficiency
timeFrame: July 2011
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Department of Haemotogy, Haemastasy, Oncology and Stem Cell Transplantation, Hannover Medical School
city: Malmö
country: Sweden
facility: Center for Thrombosis and Haemostasis, Malmo University Hospital
city: Stockholm
country: Sweden
facility: Dept Obst Gyn/Section for Women and Child Health/Clinical Trial Unit, Karolinska University Hospital
city: Truro
country: United Kingdom
facility: Treliske, Haematology Clinic, Royal Cornwall Hospital
state: Cornwall
city: Bristol
country: United Kingdom
facility: Bristol Haemophia Care Centre, Bristol Haemotology and Oncology Centre
city: Glasgow
country: United Kingdom
facility: Department of Haemotology, Glasgow Royal Infirmary
city: London
country: United Kingdom
facility: Kings College, Dept of Haematology, Lupus & Pathology Guy's and St Thomas Trust, St Thomas Hospital, Ctr for Haemostasis and Thrombosis (the Haemophia Reference Ctr)
city: London
country: United Kingdom
facility: University College London Hospital NHS Trust
Study officials:
affiliation: St Thomas' Hospital, London, UK
name: Beverley Hunt, FRCP, FRCPath MD
role: PRINCIPAL_INVESTIGATOR
References: