- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119457
Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)
June 2, 2009 updated by: vTv Therapeutics
A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Weeks Extended VTE Prophylaxis With Daily Oral Doses of TTP889 After One Week of Standard Prophylactic Treatment Following Hip Fracture Surgery
The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
FIXIT is the first Phase 2 study of TTP889.
The trial is a proof-of-concept study to determine the safety and antithrombotic efficacy of TTP889 in patients at risk for venous thromboembolism (VTE).
The study is a multi-center, randomized, double-blind, parallel-group evaluation of 300 mg TTP889 or placebo, administered orally once daily for three weeks, in patients who have undergone surgery to repair unilateral fracture of the upper third of either femur and who have completed 5 to 9 days of postoperative prophylactic treatment for VTE.
Study Type
Interventional
Enrollment
300
Phase
- Phase 2
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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Ceske Budejovice, Czech Republic, 370 87
- Nemocnice Ceske Budejovice, Urazove oddeleni
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Ostrava-Poruba, Czech Republic, 708 52
- FN s Poliklinikou Ostrava, Traumatologicke Centrum
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Praha 5, Czech Republic, 150 06
- FN Motol, Ortopedicka Klinicka UK 2.LF a FN Notol
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Praha 8, Czech Republic, 180 81
- FN Na Bulovce, Ortopedicka Klinika IPVZ a 1.LF UK ORT, Budinova 2
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Praha-2, Czech Republic, 128 08
- VFN, I. Chirurgicka klinika
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Aalborg, Denmark, 9000
- Aalborg Hospital
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Farso, Denmark, 9640
- Ortopaedkirurgisk Klinik, Farso
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Hellerup, Denmark, 2900
- Amtsygehuset i Gentofte
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Herlev, Denmark, 2730
- KAS Herlev
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Horsholm, Denmark, 2970
- Horsholm Hospital
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Kobenhavn, Denmark, 2400
- H:S Bispebjerg Hospital
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Silkeborg, Denmark, 8600
- Silkeborg Hospital
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Alesund, Norway, 6026
- Orthopedics, Alesund Sykehus
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Gjovik, Norway, 2819
- Skyehuset Innlandet HF
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Lillehammer, Norway, 2609
- Skyehuset Innlandet HF
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Tonsberg, Norway, 3116
- Halfdan Wilhelmsens Alle 17
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Goteborg, Sweden, 416 85
- Ortoped Kliniken, Sahlgrenska Universitetssjukhus, Ostra
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Kungalv, Sweden, 442 83
- Ortopedsektionen, Kirurgkliniken, Kungalvs Sjukhus
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Molndal, Sweden, 431 80
- Ortoped kliniken, Sahlgrenska Universitetssjukhus
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Udevalla, Sweden, 451 80
- Ortoped kliniken, NU-sjukvarden, Udevalla Sjukhus
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Varberg, Sweden, 432 81
- Ortoped kliniken, Sjukhuset i Varberg
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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:
- Must have undergone reparative surgery within 72 hours after unilateral hip fracture, defined as fracture of the upper third of either femur
- Must have started standard prophylactic treatment for VTE with low molecular weight heparin (LMWH) or heparin before surgery or within 24 hours after hip fracture surgery, and continued treatment with LMWH or heparin for at least five days, but not more than nine days, after surgery
- Last dose of LMWH or heparin must have been administered at least 12 hours, but not more than 48 hours, before dosing with study drug
- Females must have a negative serum pregnancy test
- Must weigh at least 45 kg
- Must demonstrate the mental and physical ability and willingness to follow all study-specific instructions
- Must be able to read, comprehend and sign the Ethics Committee-approved informed consent form
Exclusion Criteria:
- Evidence of active bleeding
- Clinical signs of VTE
- Any medical requirement for (or intention to use) continued anticoagulation after randomization through the end of study
- History of intracranial bleeding, hemorrhagic stroke, or gastrointestinal bleeding within 3 months of study start
- Presence of active malignant disease
- Hip fracture associated with multiple trauma, that places patient at excessive risk for hemorrhage or organ system failure, or that may make it difficult or impossible to perform bilateral lower limb venography
- Intention to take aspirin at doses greater than 325 mg/day
- Hemoglobin < 5.45 mmol/L (9 g/dL), hematocrit < 29%, or a platelet count < 100,000/mL at the screening visit
- Elevated ALT or AST level > 3.0 times the ULN, or an elevated total bilirubin > 1.5 the ULN at the screening visit
- Creatinine > 180 mmol/L (2.0 mg/dL) at the screening visit
- Any other laboratory value at screening that the Investigator considers to be clinically significant and warrants exclusion from the study
- Patient is currently breast feeding a child and wishes to continue breast feeding
- Previous allergy to contrast material or any other contraindications to perform bilateral lower limb venography
- The use of another investigational drug within 28 days of study entry
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the antithrombotic efficacy of TTP889, administered once daily for three weeks, in patients who have completed standard prophylactic treatment for deep vein thrombosis after hip fracture surgery.
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Evaluation of safety of once daily oral administration of TTP889 for three weeks
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Secondary Outcome Measures
Outcome Measure |
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To assess the correlation between peak and trough plasma concentrations of TTP889 and clinical safety and efficacy outcomes.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Bengt I Eriksson, MD, Dept of Orthopaedics, Goteborg University
- Study Director: David P Ward, MD, vTv Therapeutics
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
January 1, 2005
Study Completion
April 1, 2006
Study Registration Dates
First Submitted
July 5, 2005
First Submitted That Met QC Criteria
July 5, 2005
First Posted (Estimate)
July 13, 2005
Study Record Updates
Last Update Posted (Estimate)
June 3, 2009
Last Update Submitted That Met QC Criteria
June 2, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTP889-201
- Eudract CT#2004-002511-83
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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