Congenital Antithrombin DeficiencyPhase 1NCT00938288
A Study of KW-3357 in Congenital Antithrombin Deficiency
A Phase 1 study testing KW-3357 in people with Congenital Antithrombin Deficiency, run by Kyowa Kirin Co., Ltd. at 8 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Antithrombin Deficiency
- What is being tested?
- KW-3357
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Apr 2009to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United Kingdom5 sites
Bristol Haemophia Care Centre, Bristol Haemotology and Oncology Centre
Bristol, BS2 8ED
Department of Haemotology, Glasgow Royal Infirmary
Glasgow, G4 0SF
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)
London, SE1 7EH
University College London Hospital NHS Trust
London, WIT 4EU
Treliske, Haematology Clinic, Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
Sweden2 sites
Center for Thrombosis and Haemostasis, Malmo University Hospital
Malmö, SE-205 02
Dept Obst Gyn/Section for Women and Child Health/Clinical Trial Unit, Karolinska University Hospital
Stockholm, SE-171 76
Germany1 site
Department of Haemotogy, Haemastasy, Oncology and Stem Cell Transplantation, Hannover Medical School
Hanover, 30625
About this 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.
The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.
Read the 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.
- Conditions
- Congenital Antithrombin Deficiency
- Being tested
- KW-3357
- Keywords
- Antithrombin, Thrombosis, Pharmacokinetics, Hereditary Antithrombin Deficiency, Congenital Antithrombin Deficiency
- Medical subject headings
- Thrombosis, Antithrombin III Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-3357Drug
50IU/mL, IV single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Single group Receives: Drug: KW-3357 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetic profile of a single dose (50 IU/kg) of KW 3357 in subjects with congenital AT deficiency
Measured: July 2011
Secondary outcomes (1)
To determine the safety and tolerability of a single dose (50 IU/kg) of KW-3357 in subjects with congenital AT deficiency
Measured: July 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startApr 2009
- Primary completion22 Dec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Antithrombin DeficiencyStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin UK, Ltd.
- Responsible party
- Sponsor
- Investigators
- Beverley Hunt, FRCP, FRCPath MD, Principal investigator, St Thomas' Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938288
- Sponsor's protocol ID
- 3357-EU-001
- Other IDs
- EudraCT number 2008-005504-16
- Status last verified
- Oct 2024
- First submitted
- 10 Jul 2009
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00938288
- Acronym / sponsor ID
- 3357-EU-001
- Conditions
- Congenital Antithrombin Deficiency
- Keywords
- Antithrombin, Thrombosis, Pharmacokinetics, Hereditary Antithrombin Deficiency, Congenital Antithrombin Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin UK, Ltd.
- Study start
- Apr 2009
- Primary completion
- 22 Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: KW-3357Single group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KW-335750IU/mL, IV single dose | Drug | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
Related trials for Congenital Antithrombin Deficiency
RecruitingPhase 3
Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
Congenital Antithrombin Deficiency
RecruitingPhase 3
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
Acquired Antithrombin Deficiency
Not yet recruitingObservational study
Belgian Antithrombin Deficiency Registry
Antithrombin III Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverley Hunt, FRCP, FRCPath MD principal investigator
St Thomas' Hospital, London, UK
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KW-3357 in people with Congenital Antithrombin Deficiency, run by Kyowa Kirin Co., Ltd. at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Sweden, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.