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Venous ThromboembolismPhase 2NCT00119457

Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)

A Phase 2 study testing TTP889 in people with Venous Thromboembolism and Embolism and Thrombosis, run by vTv Therapeutics at 21 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
TTP889
How many people
300 participants
Where
21 sitesin 4 countries
Study dates
Jan 2005to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

21 sites in 4 countries.

21 sites in 4 countries

Denmark7 sites

  • AAlborg Hospital

    Aalborg, 9000

  • H:S Bispebjerg Hospital

    Copenhagen, 2400

  • Ortopaedkirurgisk Klinik, Farso

    Farsø, 9640

  • Amtsygehuset i Gentofte

    Hellerup, 2900

  • KAS Herlev

    Herlev, 2730

  • Horsholm Hospital

    Hørsholm, 2970

  • Silkeborg Hospital

    Silkeborg, 8600

Other trials in Denmark

Czechia5 sites

  • Nemocnice Ceske Budejovice, Urazove oddeleni

    České Budějovice, 370 87

  • FN s Poliklinikou Ostrava, Traumatologicke Centrum

    Ostrava-Poruba, 708 52

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

    Prague, 150 06

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

    Prague, 180 81

  • VFN, I. Chirurgicka klinika

    Praha-2, 128 08

Other trials in Czechia

Sweden5 sites

  • Ortoped Kliniken, Sahlgrenska Universitetssjukhus, Ostra

    Gothenburg, 416 85

  • Ortopedsektionen, Kirurgkliniken, Kungalvs Sjukhus

    Kungälv, 442 83

  • Ortoped kliniken, Sahlgrenska Universitetssjukhus

    Mölndal, 431 80

  • Ortoped kliniken, NU-sjukvarden, Udevalla Sjukhus

    Udevalla, 451 80

  • Ortoped kliniken, Sjukhuset i Varberg

    Varberg, 432 81

Other trials in Sweden

Norway4 sites

  • Orthopedics, Alesund Sykehus

    Ålesund, 6026

  • Skyehuset Innlandet HF

    Gjøvik, 2819

  • Skyehuset Innlandet HF

    Lillehammer, 2609

  • Halfdan Wilhelmsens Alle 17

    Tønsberg, 3116

Other trials in Norway

About this study

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

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

Read the 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.

Being tested
TTP889
Keywords
antithrombotic agents, anticoagulants, prophylaxis, embolism, deep vein thrombosis, hip fracture
Medical subject headings
Venous Thromboembolism, Embolism and Thrombosis, Hip Fractures, Embolism, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TTP889Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. Evaluation of safety of once daily oral administration of TTP889 for three weeks

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2005 (estimated)
  2. Study startJan 2005
  3. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00119457
Sponsor's protocol ID
TTP889-201
Other IDs
Eudract CT#2004-002511-83
Status last verified
Jun 2009
First submitted
5 Jul 2005
Last updated
3 Jun 2009
Results posted
No

Publications

  • 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.

    PubMed 18088349

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TTP889 in people with Venous Thromboembolism and Embolism and Thrombosis, run by vTv Therapeutics at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Denmark, Czechia, Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00119457, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009.

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