Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)

Phase 2

Completed

• Conditions: Venous Thromboembolism; Embolism and Thrombosis; Hip Fractures

• Registration Number: NCT00119457
• Lead Sponsor: vTv Therapeutics

Brief Summary

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

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 Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-07-05
• Study First Submitted QC: 2005-07-05
• Study First Posted: 2005-07-13
• Study Completion: 2006-04
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-02
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
Evaluation of safety of once daily oral administration of TTP889 for three weeks

Secondary Outcome Measures

Name	Time	Method
To assess the correlation between peak and trough plasma concentrations of TTP889 and clinical safety and efficacy outcomes.

Trial Locations

Locations (20)

Horsholm Hospital; 🇩🇰 Horsholm, Denmark

Orthopedics, Alesund Sykehus; 🇳🇴 Alesund, Norway

Ortoped kliniken, Sahlgrenska Universitetssjukhus; 🇸🇪 Molndal, Sweden

KAS Herlev; 🇩🇰 Herlev, Denmark

Ortoped Kliniken, Sahlgrenska Universitetssjukhus, Ostra; 🇸🇪 Goteborg, Sweden

Skyehuset Innlandet HF; 🇳🇴 Lillehammer, Norway

Halfdan Wilhelmsens Alle 17; 🇳🇴 Tonsberg, Norway

Ortopedsektionen, Kirurgkliniken, Kungalvs Sjukhus; 🇸🇪 Kungalv, Sweden

Ortoped kliniken, Sjukhuset i Varberg; 🇸🇪 Varberg, Sweden

Amtsygehuset i Gentofte; 🇩🇰 Hellerup, Denmark

AAlborg Hospital; 🇩🇰 Aalborg, Denmark

Ortopaedkirurgisk Klinik, Farso; 🇩🇰 Farso, Denmark

H:S Bispebjerg Hospital; 🇩🇰 Kobenhavn, Denmark

Silkeborg Hospital; 🇩🇰 Silkeborg, Denmark

Ortoped kliniken, NU-sjukvarden, Udevalla Sjukhus; 🇸🇪 Udevalla, Sweden

Nemocnice Ceske Budejovice, Urazove oddeleni; 🇨🇿 Ceske Budejovice, Czech Republic

FN s Poliklinikou Ostrava, Traumatologicke Centrum; 🇨🇿 Ostrava-Poruba, Czech Republic

FN Na Bulovce, Ortopedicka Klinika IPVZ a 1.LF UK ORT, Budinova 2; 🇨🇿 Praha 8, Czech Republic

VFN, I. Chirurgicka klinika; 🇨🇿 Praha-2, Czech Republic

FN Motol, Ortopedicka Klinicka UK 2.LF a FN Notol; 🇨🇿 Praha 5, Czech Republic