Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)

vTv Therapeutics

Status and phase

Completed

Phase 2

Conditions

Hip Fractures

Venous Thromboembolism

Embolism and Thrombosis

Treatments

Drug: TTP889

Study type

Interventional

Funder types

Industry

Identifiers

NCT00119457

Eudract CT#2004-002511-83

TTP889-201

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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