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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-003408-21
    Sponsor's Protocol Code Number:THO-IM_02-CT
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-10-15
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-003408-21
    A.3Full title of the trial
    A Phase II/III, randomized, controlled, single blind study to evaluate the haemostatic efficacy and safety of topically applied TT-173 in patients undergoing knee arthroplasty
    Estudio fase II/III, aleatorizado, controlado, simple ciego para evaluar la eficacia hemostática y la seguridad de TT-173 en aplicación tópica a pacientes sometidos a artroplastia de rodilla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the efficacy to stop the bleeding and safety of TT-173 applied in patients undergoing knee arthroplasty
    Estudio clínico para evaluar la eficacia para detener la hemorragia y la seguridad de TT-173 cuando se aplica a pacientes sometidos a artroplastia de rodilla
    A.3.2Name or abbreviated title of the trial where available
    HESTAT
    A.4.1Sponsor's protocol code numberTHO-IM_02-CT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThrombotargets Europe
    B.1.3.4CountrySpain
    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 supportThrombotargets Europe
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThrombotargets Europe
    B.5.2Functional name of contact pointJefe de Farmacología
    B.5.3 Address:
    B.5.3.1Street AddressAv. Canal Olimpic, s/n
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08860
    B.5.3.4CountrySpain
    B.5.4Telephone number+34936642040NA
    B.5.5Fax number+34936350712NA
    B.5.6E-mailjesusmurat@thrombotargets.com
    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 No
    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 nameTT-173
    D.3.2Product code TT-173
    D.3.4Pharmaceutical form Powder for concentrate
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNYeast-derived microvesicles containing recombinant tissue factor
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeTT-173
    D.3.9.3Other descriptive nameTT-173
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 No
    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 placeboOral liquid
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Haemostatic effect in patients undergoing knee arthroplasty
    Hemostasia en pacientes que requieren artroplastia de rodilla
    E.1.1.1Medical condition in easily understood language
    Stop the bleeding in patients undergoing knee arthroplasty
    Detención de la hemorragia en pacientes sometidos a artroplastia de rodilla
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10060663
    E.1.2Term Surgical hemostasis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the haemostatic efficacy and safety of TT-173 to reduce the total blood loss asssociated with total knee arthroplasty
    Evaluar la eficacia hemostática y la seguridad de TT-173 en la reducción de la pérdida total de sangre derivada de la artroplastia total de rodilla
    E.2.2Secondary objectives of the trial
    - To evaluate the systemic absortion of the product under the experimental conditions of the study.
    - To evaluate the local tolerability of TT-173 when it is topically applied at the end ot total knee arthroplasty.
    - To evaluate the immunogenicity of TT-173 when it is topically applied to total knee arthroplasty.
    - Evaluar la absorción sistémica del producto bajo las condiciones experimentales del estudio.
    - Evaluar la tolerabilidad local de TT-173 en su aplicación tópica una vez finalizada la artroplastia total de rodilla.
    - Evaluar la inmunogenia de TT-173 en su aplicación tópica en la artroplastia total de rodilla.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients who signed the informed consent.
    - Patients affected of degenerative osteoarthritis of the knee that have to undergo a primary total knee replacement.
    - Patients of both sexes older than 18 years.
    - Female patients in childbearing age*, that are not permanently sterile, should present a negative pregnancy test and should agree to use a medically accepted anti contraceptive method during its participation in the study. This includes oral, intravaginal, transdermal, injectable or implantable hormonal contraceptives, sexual abstinence, bilateral tubal occlusion, intrauterine hormone-releasing system or dispositive and vasectomy of the partner.
    * Includes the period between menarche and until becoming post-menopausal. A woman is considered post-menopausal when she has gone without a period for 12 consecutive months.
    - Patients must have a haemoglobin concentration greater or equal than 12,5 g/dL at the selection visit.
    - Pacientes que hayan firmado el consentimiento informado.
    - Pacientes afectados por osteoartritis degenerativa de rodilla que vayan a ser sometidos a artroplastia primaria total de rodilla.
    - Pacientes de ambos sexos mayores de 18 años.
    - Mujeres potencialmente fértiles*, que no sean permanentemente esteriles, deben presentar una prueba de embarazo negativa y deben estar dispuestas a utilizar un método anticonceptivo médicamente aprobado durante su participación en el estudio.Esto incluye anticonceptivos hormonales orales, intravaginales, transdérmicos, inyectables o implantables, la abstinencia sexual, ligamento de trompas, dispositivo o sistema de liberación hormonal intrauterino y vasectomía de la pareja.
    *Incluye el período entre la menarquia y hasta ser post-menopausica. Una mujer se considera post-menopausica cuando se le ha retirado el período por un tiempo superior a 12 meses consecutivos.
    - Pacientes con un nivel de hemoglobina mayor o igual a 12,5 g/dL en la visita de selección.
    E.4Principal exclusion criteria
    - Patients affected of any kind of congenital or acquired coagulopathies or with personal history of abnormal haemorrhagic episodes.
    - Patients subjected to knee replacement due to rheumatoid or seronegative arthritis, infection or other autoimmune inflammatory causes of join degeneration.
    - Patients subjected to revision procedures of the knee, hemiarthroplasty or that will receive non-cemented knee prosthesis.
    - Subjects affected of a serious medical condition that would compromise their clinical outcome such as hepatic, respiratory, cardiac or renal insufficiency, acute infectious disease and active cancer.
    - Subjects with known history of haematological alterations which are causative of thrombophilia.
    - Subjects with personal history of deep vein thrombosis, pulmonary thromboembolism, retinal vascular occlusion or multiple abortions.
    - Subjects with known hypersensitivity or allergy to any component of the drug.
    - Subjects that require treatment with anticoagulant, antiplatelet or antifibrinolytic drugs.
    - Subjects who have received treatment (erythropoietin, iron, folate) to improve preopeartive anaemia.
    - Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.
    - Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.
    - Subjects that are the investigators, collaborators, nurses, centre employees or any other person directly related to the development of the protocol.
    - Subjects who are pregnant or lactating.
    - Pacientes afectados de cualquier tipo de coagulopatía congénita o adquirida o con historia personal de episodios hemorrágicos.
    - Pacientes sometidos a artroplastia de rodilla debido a artritis reumatoide o seronegativa, infección u otra causa inflamatoria autoinmune de degeneración articular.
    - Pacientes sometidos a procedimientos de revisión de rodilla, hemiartroplastia o que recibirán una prótesis de rodilla no cementada.
    - Pacientes afectados de una condición médica grave que pueda comprometer su evolución clínica como enfermedad hepática, respiratoria, cardiaca o insuficiencia renal , enfermedad infecciosa aguda o cáncer activo.
    - Pacientes con historia conocida de alteraciones hematológicas que puedan ser causa de trombofilia.
    - Pacientes con historia personal de trombosis venosa profunda, tromboembolismo pulmonar, oclusión vascular retiniana o abortos múltiples.
    - Pacientes con hipersensibilidad o alergia conocidas a cualquier componente del producto.
    - Pacientes que requieren tratamiento con fármacos anticoagulantes, antiplaquetarios o antifibrinolíticos.
    - Pacientes que reciben tratamiento preoperatorio (eritropoyetina, hierro o folatos) para mejorar la anemia.
    - Pacientes que no son libres de dar su consentimiento informado o a que a discreción de los investigadores están mentalmente incapacitados.
    - Pacientes que participan o han participado en los últimos tres meses en otro ensayo clínico con tratamiento farmacológico.
    - Pacientes que son investigadores, colaboradores, personal de enfermería, trabajadores del centro o cualquier otra persona directamente relacionada con el desarrollo del protocolo.
    - Mujeres embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence and severity of adverse events.
    - Total blood loss defined according to Nadler's formula.
    - Incidencia y gravedad de acontecimientos adversos.
    - Pérdida total de sangre, definida mediante la fórmula de Nadler.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    Al finalizar el estudio.
    E.5.2Secondary end point(s)
    - Maximum decrease in venous haemoglobin concentration.
    Blood collected in the drainage during the first 24 hours.
    - Hidden blood loss.
    - Transfusion rate defined as the percentage of patients that receive blood concentration units to treat acute anaemia.
    - Number of units of blood concentrates transfused.
    - Range of knee motion.
    - Systemic absorption of the product defined as detectable increase of tissue factor (TF) blood concentration at any time of the pharmacokinetics sampling compared to basaline level.
    - Immunogenicity of the product defined as a detectable increase of reactive antibodies against the product at 35 +/- 7 days after surgery compared to baseline levels.
    - Disminución máxima de la concentración de hemoglobina en sangre venosa.
    - Volumen de sangre recogido en el drenaje durante las primeras 24 horas.
    - Perdida oculta de sangre.
    - Tasa transfusional, definida como el porcentaje de pacientes que reciben unidades de concentrados de hematíes para el tratamiento de una anemia aguda.
    - Unidades de concentrados de hematíes transfundidos.
    - Rango de movimiento de la rodilla.
    - Absorción sistémica del producto, definida como aumento detectable de la concentración del factor tisular en cualquiera de las muestras para farmacocinética en comparación con su valor basal.
    - Inmunogenia del producto definida como aumento detectable de los anticuerpos reactivos frente al producto a los 35 +/- 7 días después de la cirugía, en comparación con los niveles basales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    Al finalizar el estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.4Double blind No
    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.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States No
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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 Patient Last Visit
    Última visita último paciente
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state210
    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)
    Standard care.
    Tratamiento habitual.
    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 Decision2015-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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