Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-005419-18
    Sponsor's Protocol Code Number:01INMUNOGEST14
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-20
    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 number2014-005419-18
    A.3Full title of the trial
    CLINICAL TRIAL, PHASE III, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED WITH INTRAVENOUS IMMUNOGLOBULIN HUMAN FOR THE TREATMENT OF REPEAT ABORTION WITH IMMUNE ETIOLOGY
    PROTOCOLO ENSAYO CLÍNICO FASE III ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE INMUNOGLOBULINA HUMANA INTRAVENOSA PARA EL TRATAMIENTO DEL ABORTO DE REPETICIÓN DE ETIOLOGÍA INMUNOLÓGICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INTRAVENOUS IMMUNOGLOBULIN HUMAN FOR THE TREATMENT OF ABORTION
    INMUNOGLOBULINA HUMANA INTRAVENOSA PARA EL TRATAMIENTO DEL ABORTO
    A.3.2Name or abbreviated title of the trial where available
    INMUNOGEST
    A.4.1Sponsor's protocol code number01INMUNOGEST14
    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 Sponsorsilvia sanchez ramon
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportfundación para la investigación del hospital clinico san carlos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationhospital clinico san carlos
    B.5.2Functional name of contact pointunidad de inmunología
    B.5.3 Address:
    B.5.3.1Street Addressprofesor martin lagos s/n
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number349133027742774
    B.5.5Fax number349133035153515
    B.5.6E-mailfibucicec.hcsc@salud.madrid.org
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIg IV
    D.3.9.1CAS number Ig IV
    D.3.9.2Current sponsor codeIg IV
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN
    D.3.9.4EV Substance CodeSUB14196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    recurrent aborption with inmunological etiology
    abortos recurrentes de etiologia inmunologica
    E.1.1.1Medical condition in easily understood language
    recurrent aborption
    abortos recurrentes
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10072314
    E.1.2Term Pregnancy loss
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that treatment with IVIG in patients with recurrent abortions and expansion of NK and NKT cells in peripheral blood increases the proportion of live births.
    Demostrar que el tratamiento con IgIV en pacientes con abortos recurrentes y expansión de células NK y NKT en sangre periférica aumenta la proporción de recién nacidos vivos.
    E.2.2Secondary objectives of the trial
    ? To evaluate the profile of Th1 / Th2 / Th17 / Treg and chemokines in plasma prior to and during treatment with IVIG in patients with recurrent abortions.
    ? To evaluate the percentage and phenotype of NK cells and T regulatory circulating before and during treatment with IVIG in patients with recurrent abortions.
    ? To assess the safety of IVIg in patients with recurrent abortions.
    ? To evaluate the safety of live births to mothers exposed to IVIG.
    ? To evaluate the quality of life of mothers of newborns alive after IVIG administration.
    Evaluar el perfil de citoquinas Th1/Th2/Th17/Treg y quimioquinas en plasma previamente y durante el tratamiento con IgIV en pacientes con abortos recurrentes.
    Evaluar el porcentaje y fenotipo de células NK y T reguladoras circulantes antes y durante el tratamiento con IgIV en pacientes con abortos recurrentes.
    Evaluar la seguridad de la administración de IgIV en pacientes con abortos recurrentes.
    Evaluar la seguridad de los recién nacidos vivos de madres expuestas a IgIV.
    Evaluar la calidad de vida de las madres de recién nacidos vivos tras la administración de IgIV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed informed consent before any assessment and intervention on the patient.
    Women with three consecutive spontaneous abortions, 18 to 37 years of age, inclusive
    Circulating cytotoxic NK cells (CD3-CD56 + CD16 +) with a value of "13% of total lymphocytes in 35 years or more" and "less than 22% in 35 years" or "NKT cells ?10% of total lymphocytes" .
    Weight Between 40 kg and 90 kg, inclusive.
    Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
    El consentimiento informado firmado por escrito, que debe ser obtenido antes de realizar cualquier evaluación e intervención sobre la paciente.
    -Mujeres con tres abortos espontáneos consecutivos, de 18 a 37 años de edad, ambos inclusive (en el momento de la visita de selección).
    - Células NK citotóxicas circulantes (CD3-CD56+CD16+) con valor de "13% de los linfocitos totales en 35 años o más? y "22% en menores de 35 años? o ?células NKT ?10% de los linfocitos totales?.
    -Peso comprendido entre los 40 kg y 90 kg, ambos incluidos.
    -Capacidad de comunicarse bien con el investigador, para entender y cumplir con los requisitos del estudio.
    E.4Principal exclusion criteria
    Medication use prohibited in the study.
    Known hypersensitivity to immunoglobulins
    Recent clinically significant bacterial infection.
    Immunodeficiency diseases, including HIV.
    Hepatitis B or C and / or positive hepatitis B surface antigen (HBsAg) or hepatitis C test at screening, at the present time.
    Alcohol abuse at present or during the previous 12 months.
    Participation in any clinical trial with an experimental drug or affect the ability or maintenance of conception in the 4 weeks prior to the first dose.
    Any other condition in the investigator's opinion may make the patient inappropriate for entry into the study.
    Uso de medicación prohibida en el estudio.
    Antecedentes de hipersensibilidad a inmunoglobulinas
    Infección bacteriana reciente clínicamente significativa.
    Enfermedades inmunodeficientes, incluyendo VIH.
    Hepatitis B o C y / o antígeno positivo hepatitis B de superficie (HBsAg) o la prueba de la hepatitis C en el cribado, en el momento actual.
    Abuso de alcohol en el momento actual o durante los 12 meses previos.
    Participación en cualquier ensayo clínico con un medicamento experimental o que influya en la capacidad o el mantenimiento de la concepción en las 4 semanas previas a la primera dosis.
    Cualquier otra condición que en opinión del investigador puedan hacer que el paciente sea inapropiado para entrar en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    new born number
    número de gestaciones con Recién Nacidos Vivos
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the pregnancy
    al final del embarazo
    E.5.2Secondary end point(s)
    1. Number of pregnancies achieved
    2. Quality of Life
    3. Gestation time
    4. Proportion of congenital malformations.
    5. Rate of postpartum infection
    6. Percentile of height, weight and head circumference of the newborn
    7. Newborn neurologic development
    1.Consecución de gestación
    2.Calidad de Vida de las pacientes
    3.Tiempo de gestación total.
    4.Proporción de malformaciones congénitas.
    5.Tasa de infecciones en el postparto
    6.Percentil de talla, peso y perímetro craneal del recién nacido
    7.Desarrollo neurológico del recién nacido
    E.5.2.1Timepoint(s) of evaluation of this end point
    3-4 after pregncancy
    cada tres o cuatro semanas posterior al embarazo
    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 Yes
    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 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) No
    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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    6 months
    seis meses
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 66
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 No
    F.3.3.3Pregnant women Yes
    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 state66
    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)
    Newborn follow-up visit (+6, +12 months): growth, weight gain and neurological development will be assessed. The occurrence of infections are monitored within the first 12 months of life.
    Visita de Seguimiento (+ 6, +12 meses) del recién nacido: se evaluará el crecimiento, ganancia de peso y desarrollo neurológico. Se monitorizará la aparición de infecciones en los 12 primeros meses de vida
    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 Decision2016-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-01
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 03 10:39:48 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA