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Thrombosis, VenousPhase 3NCT00911157

The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

A Phase 3 study testing Fondaparinux sodium and unfractionated heparin (UFH) in people with Thrombosis, Venous, run by GlaxoSmithKline at 24 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Thrombosis, Venous
What is being tested?
Fondaparinux sodium and unfractionated heparin (UFH)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
24 sitesJapan
Study dates
Jun 2008to Nov 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 25Show fewer
  • 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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Japan24 sites

  • GSK Investigational Site

    Aichi, 440-8510

  • GSK Investigational Site

    Fukuoka, 802-8555

  • GSK Investigational Site

    Gunma, 370-0829

  • GSK Investigational Site

    Gunma, 371-8511

  • GSK Investigational Site

    Hiroshima, 720-8520

  • GSK Investigational Site

    Hiroshima, 739-0651

  • GSK Investigational Site

    Hokkaido, 006-8555

  • GSK Investigational Site

    Hokkaido, 060-8543

  • GSK Investigational Site

    Hokkaido, 060-8648

  • GSK Investigational Site

    Hyōgo, 654-0155

  • GSK Investigational Site

    Ibaraki, 305-8576

  • GSK Investigational Site

    Ibaraki, 311-3193

  • GSK Investigational Site

    Kagoshima, 892-0853

  • GSK Investigational Site

    Kanagawa, 245-8575

  • GSK Investigational Site

    Kumamoto, 860-0008

  • GSK Investigational Site

    Kumamoto, 860-8556

  • GSK Investigational Site

    Mie, 514-8507

  • GSK Investigational Site

    Nagano, 399-0021

  • GSK Investigational Site

    Nagasaki, 859-3615

  • GSK Investigational Site

    Niigata, 951-8520

  • GSK Investigational Site

    Okayama, 701-1192

  • GSK Investigational Site

    Shizuoka, 430-8558

  • GSK Investigational Site

    Shizuoka, 438-8550

  • GSK Investigational Site

    Tokyo, 113-8655

Other trials in Japan

About this study

Official title: 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.

Being tested
Fondaparinux sodium, unfractionated heparin (UFH)
Keywords
Pulmonary thromboembolism, contrast-enhanced MDCT, Deep Vein Thrombosis, Fondaparinux sodium
Medical subject headings
Venous Thrombosis, Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fondaparinux sodiumDrug

    Also called GSK576428

    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.

  • unfractionated heparin (UFH)Drug

    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.

Study groups in NCT00911157
Study groupRoleWhat they receive
FondaparinuxExperimentalNot described
Receives: Drug: Fondaparinux sodium
unfractionated heparinOtherNot described
Receives: Drug: unfractionated heparin (UFH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)

    VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).

    Measured: From Day 1 to Day 90 (±7 days)

Secondary outcomes (4)

  1. Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)

    VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE.

    Measured: From Day 1 to Day 90 (±7 days)

  2. Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline

    Classifications of "Improved," "No change," or "Worse" were adjudicated blindly by the CIACE.

    Measured: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)

  3. Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10

    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).

    Measured: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)

  4. Percentage of Participants With a Bleeding Event

    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).

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2009 (estimated)
  2. Study startJun 2008
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911157
Sponsor's protocol ID
111436
Status last verified
Oct 2016
First submitted
28 May 2009
Last updated
23 Nov 2016
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Nakamura M, Okano Y, Minamiguchi H, Munemasa M, Sonoda M, Yamada N, Hanzawa K, Aoyagi N, Tsujimoto H, Sarai N, Nakajima H, Kunieda T. Multidetector-row computed tomography-based clinical assessment of fondaparinux for treatment of acute pulmonary embolism and acute deep vein thrombosis in Japanese patients. Circ J. 2011;75(6):1424-32. doi: 10.1253/circj.cj-10-1036. Epub 2011 Apr 22.

    PubMed 21512258

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fondaparinux sodium and unfractionated heparin (UFH) in people with Thrombosis, Venous, run by GlaxoSmithKline at 24 sites in Japan.

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 5 inclusion and 25 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (time frame: From Day 1 to Day 90 (±7 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00911157, which also lists 1 linked publication.

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 23 Nov 2016.

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