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

Condition	Intervention	Phase
Venous Thromboembolism Embolism and Thrombosis Hip Fractures	Drug: TTP889	Phase II

Further Study Details: 

Primary Outcomes: 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 Outcomes: To assess the correlation between peak and trough plasma concentrations of TTP889 and clinical safety and efficacy outcomes.
Expected Total Enrollment:  300

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00119457

Alison Martin      44 118 933 5364    Alison.Martin@mdsps.com

Czech Republic
      FN Na Bulovce, Ortopedicka Klinika IPVZ a 1.LF UK ORT, Budinova 2, Praha-8,  180 81,  Czech Republic; Recruiting
      Nemocnice Ceske Budejovice, Urazove oddeleni, Ceske Budejovice,  370 87,  Czech Republic; Recruiting
      VFN, I. Chirurgicka klinika, Praha-2,  128 08,  Czech Republic; Recruiting
      FN s Poliklinikou Ostrava, Traumatologicke Centrum, Ostrava-Poruba,  708 52,  Czech Republic; Recruiting
      FN Motol, Ortopedicka Klinicka UK 2.LF a FN Notol, Praha 5,  150 06,  Czech Republic; Recruiting
Denmark
      KAS Herlev, Herlev,  2730,  Denmark; Recruiting
      Silkeborg Hospital, SILKEBORG,  8600,  Denmark; Recruiting
      H:S Bispebjerg Hospital, Kobenhavn,  2400,  Denmark; Recruiting
      Horsholm Hospital, HORSHOLM,  2970,  Denmark; Recruiting
      Amtsygehuset i Gentofte, Hellerup,  2900,  Denmark; Recruiting
      AAlborg Hospital, Aalborg,  9000,  Denmark; Recruiting
      Ortopaedkirurgisk Klinik, Farso, Farso,  9640,  Denmark; Recruiting
Norway
      Halfdan Wilhelmsens Alle 17, Tonsberg,  3116,  Norway; Recruiting
      Orthopedics, Alesund Sykehus, Alesund,  6026,  Norway; Recruiting
      Skyehuset Innlandet HF, Gjovik,  2819,  Norway; Recruiting
      Skyehuset Innlandet HF, Lillehammer,  2609,  Norway; Recruiting
Sweden
      Ortoped Kliniken, Sahlgrenska Universitetssjukhus, Ostra, Goteborg,  416 85,  Sweden; Recruiting
      Ortopedsektionen, Kirurgkliniken, Kungalvs Sjukhus, Kungalv,  442 83,  Sweden; Recruiting
      Ortoped kliniken, Sahlgrenska Universitetssjukhus, Molndal,  431 80,  Sweden; Recruiting
      Ortoped kliniken, Sjukhuset i Varberg, Varberg,  432 81,  Sweden; Recruiting
      Ortoped kliniken, NU-sjukvarden, Udevalla Sjukhus, Udevalla,  451 80,  Sweden; Recruiting

Study chairs or principal investigators

Bengt I Eriksson, MD,  Study Chair,  Dept of Orthopaedics, Goteborg University   

Study ID Numbers:  TTP889-201; Eudract CT#2004-002511-83
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 12, 2005
ClinicalTrials.gov Identifier:  NCT00119457
Health Authority: Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Czech Republic: State Institute for Drug Control
ClinicalTrials.gov processed this record on 2005-07-26