Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)

This study has been completed.
Sponsor:
Information provided by:
TransTech Pharma
ClinicalTrials.gov Identifier:
NCT00119457
First received: July 5, 2005
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by TransTech Pharma:

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

Estimated Enrollment: 300
Study Start Date: January 2005
Estimated Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119457

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

No publications provided by TransTech Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00119457     History of Changes
Other Study ID Numbers: TTP889-201, Eudract CT#2004-002511-83
Study First Received: July 5, 2005
Last Updated: June 2, 2009
Health Authority: Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
Czech Republic: State Institute for Drug Control

Keywords provided by TransTech Pharma:
antithrombotic agents
anticoagulants
prophylaxis
embolism
deep vein thrombosis
hip fracture

Additional relevant MeSH terms:
Embolism
Embolism and Thrombosis
Fractures, Bone
Hip Fractures
Thromboembolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Femoral Fractures
Hip Injuries
Leg Injuries
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014