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    Summary
    EudraCT Number:2004-002511-83
    Sponsor's Protocol Code Number:TTP889-201
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-10-29
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2004-002511-83
    A.3Full title of the trial
    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
    A.3.2Name or abbreviated title of the trial where available
    FIXIT
    A.4.1Sponsor's protocol code numberTTP889-201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTransTech Pharma
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTTP889
    D.3.2Product code TTP889
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 660826-14-2
    D.3.9.2Current sponsor codeTTP889
    D.3.9.3Other descriptive namearylcarboxamide carboxylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Antithrombotic in patients at risk for venous thromboembolism
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7
    E.1.2Level LLT
    E.1.2Classification code 10047249
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    To evaluate the safety of TTP889.
    E.2.2Secondary objectives of the trial
    To assess the possible correlation between peak and trough plasma concentrations of TTP889 and clinical safety and efficacy outcomes.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients (male or female and of any race) must be at least 18 years old.
    Female subjects must be postmenopausal (with amenorrhea for at least 2 years prior to study entry) or surgically sterile (tubal ligation, hysterectomy and/or bilateral oophorectomy).
    Female subjects must have a negative serum or urine pregnancy test
    Patients must weigh at least 45 kg.
    Patients must have undergone reparative surgery within 72 hours after unilateral hip fracture, defined as fracture of the upper third of either femur.
    Patients must have started standard prophylactic treatment for VTE with LMWH before surgery (preoperative dosing) or within 24 hours after hip fracture surgery and continued treatment with LMWH for at least five days, but not more than nine days, after surgery.
    The last dose of LMWH must have been administered at least 12 hours, but not more than 48 hours, before dosing with study drug.
    The investigator and patient must agree on a plan to assure the completion of the Day 7 Interim Visit and Day 21 Final Visit.
    The patient must demonstrate the mental and physical ability and willingness to follow all study-specific instructions, understand the explanation of the study and be able to read, comprehend and sign the Ethics Committee-approved informed consent form before initiation of any study-specific procedure.
    E.4Principal 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.
    Bleeding tendency after the current hip fracture surgery.
    Known bleeding disorder or diathesis.
    Any history of intracranial bleeding or hemorrhagic stroke or gastrointestinal bleeding within 3 months of study start.
    The presence of active malignant disease.
    Hip fracture associated with multiple trauma, that places the patient at excessive risk for hemorrhage or organ system failure, or that may make it difficult or impossible to perform bilateral lower limb venography.
    The intention to take aspirin at doses greater than 325 mg/day. [Note: The use of non-steroidal anti-inflammatory drugs (NSAIDS) should be discouraged, but is not cause for exclusion.]
    Hemoglobin < 4.85 mmol/L (8 g/dL), hematocrit less than 26%, or a platelet count less than 100,000/mL at the screening visit.
    Evidence of hepatic impairment as indicated by an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 3.0 times the upper limit of normal (ULN) or an elevated total bilirubin > 1.5 times the ULN at the screening visit.
    Creatinine > 180 µmol/L (2.0 mg/dL) at the screening visit.
    Any other laboratory value at the screening visit that is outside the laboratory-specified normal (reference) range and considered by the investigator to be a clinically significant abnormality that warrants the exclusion of the patient from the study.
    Previous allergy to contrast material or any other contraindication or foreseen difficulties to perform bilateral lower limb venography.
    The use of an investigational drug of any kind within 28 days or 5 times the elimination half-life of the drug (whichever is longer) of initial dosing of study drug.
    Patient is currently breast-feeding a child and wishes to continue breast feeding.
    Any medical requirement for (or the intention to use) Phenytoin,Tolbutamide, or Warfarin after randomization through the end of study.
    Having any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in this clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the occurrence of VTE, defined as the presence of asymptomatic deep vein thrombosis (DVT) determined by mandatory end-of-study (Day 21) bilateral lower limb venography, as adjudicated by the Adjudication Committee/Venography (AC/V), or the occurrence of a VTE event (symptomatic DVT, fatal pulmonary embolism [PE] or non-fatal PE) during the course of study treatment, as adjudicated by the Adjudication Committee/Venous Thromboembolic Event (AC/VTE).

    Statistical analysis of the primary endpoint will be performed with the Mantel-Haenszel statistic stratified by investigator site. The testing rule will be one-sided to detect greater patient response to TTP889 and alpha will be set at 0.05. Significance of potential covariates will be examined as ad-hoc analyses using the Mantel-Haenszel statistic (potentially the non-parametric extension to avoid power loss due to sparse strata).

    Only those patients who receive at least one dose of study medication and who have an adequate assessment for VTE by Day 21 will be included in the analysis of the primary efficacy endpoint. Patients having an adequate assessment of VTE by Day 21 is defined as those patients who underwent bilateral venography at the Day 21 Final Visit and who have a venogram that is judged to be adequate for evaluation by the AC/V, or patients with a definite diagnosis of a VTE event, as adjudicated by the AC/VTE, during the course of study treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Additional follow-up and reporting of any ongoing adverse events or new post-dose adverse events observed during the final visit (including any clinically-significant worsening of a laboratory parameter) should be conducted at appropriate intervals, as determined by the investigator, until the condition clears or returns to baseline. Otherwise, the patient may be returned to the care of his/her physician(s).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-03-13
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