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Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00119457
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : June 3, 2009
Information provided by:
vTv Therapeutics

Brief Summary:
The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Embolism and Thrombosis Hip Fractures Drug: TTP889 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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
Study Start Date : January 2005
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.
  2. Evaluation of safety of once daily oral administration of TTP889 for three weeks

Secondary Outcome Measures :
  1. To assess the correlation between peak and trough plasma concentrations of TTP889 and clinical safety and efficacy outcomes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00119457

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Sponsors and Collaborators
vTv Therapeutics
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Study Chair: Bengt I Eriksson, MD Dept of Orthopaedics, Goteborg University
Study Director: David P Ward, MD vTv Therapeutics
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00119457    
Other Study ID Numbers: TTP889-201
Eudract CT#2004-002511-83
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009
Keywords provided by vTv Therapeutics:
antithrombotic agents
deep vein thrombosis
hip fracture
Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Fractures, Bone
Hip Fractures
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Femoral Fractures
Hip Injuries
Leg Injuries