- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00911157
The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients
October 11, 2016 updated by: GlaxoSmithKline
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT)
The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and Deep Vein Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-label design.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi, Japan, 440-8510
- GSK Investigational Site
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Fukuoka, Japan, 802-8555
- GSK Investigational Site
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Gunma, Japan, 370-0829
- GSK Investigational Site
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Gunma, Japan, 371-8511
- GSK Investigational Site
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Hiroshima, Japan, 720-8520
- GSK Investigational Site
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Hiroshima, Japan, 739-0651
- GSK Investigational Site
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Hokkaido, Japan, 060-8648
- GSK Investigational Site
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Hokkaido, Japan, 060-8543
- GSK Investigational Site
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Hokkaido, Japan, 006-8555
- GSK Investigational Site
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Hyogo, Japan, 654-0155
- GSK Investigational Site
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Ibaraki, Japan, 305-8576
- GSK Investigational Site
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Ibaraki, Japan, 311-3193
- GSK Investigational Site
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Kagoshima, Japan, 892-0853
- GSK Investigational Site
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Kanagawa, Japan, 245-8575
- GSK Investigational Site
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Kumamoto, Japan, 860-8556
- GSK Investigational Site
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Kumamoto, Japan, 860-0008
- GSK Investigational Site
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Mie, Japan, 514-8507
- GSK Investigational Site
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Nagano, Japan, 399-0021
- GSK Investigational Site
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Nagasaki, Japan, 859-3615
- GSK Investigational Site
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Niigata, Japan, 951-8520
- GSK Investigational Site
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Okayama, Japan, 701-1192
- GSK Investigational Site
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Shizuoka, Japan, 430-8558
- GSK Investigational Site
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Shizuoka, Japan, 438-8550
- GSK Investigational Site
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Tokyo, Japan, 113-8655
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of acute proximal DVT based on contrast-enhanced Multi detector-row CT (MDCT) (not more than 10 days after the onset of the symptoms of DVT)
- Age:20 years
- Gender: No restriction
- Hospitalization status: Subjects who are able to stay at the hospital at least during the initial treatment period
- Written informed consent from the subject him/herself or his/her legally acceptable representative. Written informed consent from the subject's legally acceptable representative must be obtained if the subject is incapable of giving consent
Exclusion Criteria:
- Symptomatic PE
- Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current DVT
- Subjects (for example, with free-floating thrombus in the femoral vein or ilium by MDCT at screening) for whom insertion of inferior vena cava filter is indicated or subjects in whom inferior vena cava filter is present
- Anticoagulant therapy for at least 24 hours to treat the current episode prior to entry into the study
- Active, clinically significant bleeding
- Thrombocytopenia (platelet count <10×10⁴/µL at screening)
- Concurrent conditions with bleeding risk (e.g., ulcer of the gastrointestinal tract, diverticulitis of the gastrointestinal tract, colitis, acute bacterial endocarditis, severe hypertension, or severe diabetes) or bleeding tendency
- Severe hepatic disorder
- Known hypersensitivity to heparin, low-molecular-weight heparin (LMWH) or warfarin
- Previous history of cerebral hemorrhage
- Brain, spinal, or ophthalmological surgery within 3 months prior to entry into this study
- Previous history of Heparin-induced thrombocytopenia
- Patients for whom anticoagulant therapy is contraindicated or who cannot be taken off anticoagulant therapy due to coexistent condition (e.g. prosthetic heart valve implant)
- Severe renal disorder (serum creatinine >2.0 mg/dL [180 µmol/L] at screening) in a well hydrated subject
- QT interval prolonged (QT interval corrected by Bazett's formula [QTcB] ≥450 msec; for patients with bundle branch block QTcB ≥480 msec) at screening
- Documented hypersensitivity to contrast media
- Use of any contraindicated drug that cannot be combined with the injection of contrast medium [e.g., antihyperglycemics, such as biguanides (metformin hydrochloride, buformin hydrochloride)]
- Participation in any other therapeutic drug study or a clinical study within 6 months prior to entry into this study
- Previous participation in a study of GSK576428 [Fondaparinux Sodium; including the studies of Org31540/SR90107A (ex-project code)] or previous exposure to the therapeutic dose of GSK576428
- Drug or alcohol abuse
- Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
- Recent surgery within 3 days prior to entry into the study
- Life expectancy <3 months
- Pregnant women, nursing mothers, women who may be pregnant, or women contemplating pregnancy during the study period
- Others whom the investigator or subinvestigator considers not eligible for the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fondaparinux
|
The dose of Fondaparinux will be determined based on a subject's body weight (< 50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection.
Other Names:
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Other: unfractionated heparin
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UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
Time Frame: From Day 1 to Day 90 (±7 days)
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VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).
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From Day 1 to Day 90 (±7 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)
Time Frame: From Day 1 to Day 90 (±7 days)
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VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE.
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From Day 1 to Day 90 (±7 days)
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Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline
Time Frame: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
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Classifications of "Improved," "No change," or "Worse" were adjudicated blindly by the CIACE.
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Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
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Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10
Time Frame: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
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Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score.
The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE.
Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).
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Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
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Percentage of Participants With a Bleeding Event
Time Frame: Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).
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Bleeding events (major bleeding [clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin >=2 grams (g)/deciliter (dL), or a transfusion >=2 units]; minor bleeding [clinically overt bleeding and not adjudicated as major bleeding], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).
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Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
May 28, 2009
First Submitted That Met QC Criteria
May 29, 2009
First Posted (Estimate)
June 1, 2009
Study Record Updates
Last Update Posted (Estimate)
November 23, 2016
Last Update Submitted That Met QC Criteria
October 11, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Thrombosis
- Venous Thrombosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Heparin
- Calcium heparin
- Fondaparinux
- PENTA
Other Study ID Numbers
- 111436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Dataset Specification
Information identifier: 111436Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 111436Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 111436Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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