Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)

NCT00119457 | Completed Phase 2

• 2 other identifiers: TTP889-201Eudract CT#2004-002511-83
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 21

Brief Summary

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

Conditions

Venous Thromboembolism; Embolism and Thrombosis; Hip Fractures

Keywords

antithrombotic agents; anticoagulants; prophylaxis; embolism; deep vein thrombosis; hip fracture

Outcome Measures

Primary Outcomes (2)

• 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 (1)

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

Interventions

TTP889 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• vTv Therapeutics: lead

Study Sites (21)

Nemocnice Ceske Budejovice, Urazove oddeleni

České Budějovice, 370 87, Czechia

Location

FN s Poliklinikou Ostrava, Traumatologicke Centrum

Ostrava-Poruba, 708 52, Czechia

Location

FN Motol, Ortopedicka Klinicka UK 2.LF a FN Notol

Prague, 150 06, Czechia

Location

FN Na Bulovce, Ortopedicka Klinika IPVZ a 1.LF UK ORT, Budinova 2

Prague, 180 81, Czechia

Location

VFN, I. Chirurgicka klinika

Praha-2, 128 08, Czechia

Location

AAlborg Hospital

Aalborg, 9000, Denmark

Location

H:S Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Ortopaedkirurgisk Klinik, Farso

Farsø, 9640, Denmark

Location

Amtsygehuset i Gentofte

Hellerup, 2900, Denmark

Location

KAS Herlev

Herlev, 2730, Denmark

Location

Horsholm Hospital

Hørsholm, 2970, Denmark

Location

Silkeborg Hospital

Silkeborg, 8600, Denmark

Location

Orthopedics, Alesund Sykehus

Ålesund, 6026, Norway

Location

Skyehuset Innlandet HF

Gjøvik, 2819, Norway

Location

Skyehuset Innlandet HF

Lillehammer, 2609, Norway

Location

Halfdan Wilhelmsens Alle 17

Tønsberg, 3116, Norway

Location

Ortoped Kliniken, Sahlgrenska Universitetssjukhus, Ostra

Gothenburg, 416 85, Sweden

Location

Ortopedsektionen, Kirurgkliniken, Kungalvs Sjukhus

Kungälv, 442 83, Sweden

Location

Ortoped kliniken, Sahlgrenska Universitetssjukhus

Mölndal, 431 80, Sweden

Location

Ortoped kliniken, NU-sjukvarden, Udevalla Sjukhus

Udevalla, 451 80, Sweden

Location

Ortoped kliniken, Sjukhuset i Varberg

Varberg, 432 81, Sweden

Location

Related Publications (1)

• Eriksson BI, Dahl OE, Lassen MR, Ward DP, Rothlein R, Davis G, Turpie AG; Fixit Study Group. Partial factor IXa inhibition with TTP889 for prevention of venous thromboembolism: an exploratory study. J Thromb Haemost. 2008 Mar;6(3):457-63. doi: 10.1111/j.1538-7836.2007.02872.x. Epub 2007 Dec 12.

  PMID: 18088349 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Embolism and Thrombosis; Hip Fractures; Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Thromboembolism; Vascular Diseases; Cardiovascular Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Thrombosis

Study Officials

• Bengt I Eriksson, MD

  Dept of Orthopaedics, Goteborg University

  STUDY CHAIR

• David P Ward, MD

  vTv Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 5, 2005
• First Posted: July 13, 2005
• Study Start: January 1, 2005
• Study Completion: April 1, 2006
• Last Updated: June 3, 2009

Record last verified: 2009-06

Locations

SE (5); CZ (5); DK (7); NO (4)