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    Summary
    EudraCT Number:2012-000083-24
    Sponsor's Protocol Code Number:0624-206
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2012-03-29
    Trial results View 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 number2012-000083-24
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, DOSERANGING, CROSSOVER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF CINRYZE® (C1 ESTERASE INHIBITOR [HUMAN]) WITH RECOMBINANT HUMAN HYALURONIDASE (rHuPH20) FOR THE PREVENTION OF ANGIOEDEMA ATTACKS IN ADOLESCENTS AND ADULTS WITH HEREDITARY ANGIOEDEMA
    ESTUDIO MULTICÉNTRICO DE FASE 2, ALEATORIZADO, DOBLE CIEGO, DE RANGO DE DOSIS Y CRUZADO, PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE LA ADMINISTRACIÓN SUBCUTÁNEA DE CINRYZE®
    (INHIBIDOR DE LA ESTERASA C1 [HUMANO]) CON HIALURONIDASA HUMANA RECOMBINANTE (rHuPH20) PARA LA PREVENCIÓN DE LAS CRISIS DE ANGIOEDEMA EN ADOLESCENTES Y ADULTOS CON ANGIOEDEMA HEREDITARIO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Safety and Efficacy of Subcutaneous Administration of Cinryze with Recombinant Human Hyaluronidase for the Prevention of HAE Attacks
    Un estudio de seguridad y eficacia de la administración subcutánea de Cinryze con hialuronidasa humana recombinante para la prevención de crisis de angioedema hereditario.
    A.4.1Sponsor's protocol code number0624-206
    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 SponsorViroPharma Incorporated
    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 supportViroPharma SPRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViropharma SPRL
    B.5.2Functional name of contact pointDanielle Tierens
    B.5.3 Address:
    B.5.3.1Street AddressRue Montoyer 47
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32027470971
    B.5.5Fax number+32027062421
    B.5.6E-maildanielle.tierens@viropharma.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 Yes
    D.2.1.1.1Trade name Cinryze
    D.2.1.1.2Name of the Marketing Authorisation holderViropharma SPRL
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameINHIBIDOR DE LA ESTERASA C1 COMPLEMENTO
    D.3.9.4EV Substance CodeSUB22696
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Angioedema.
    Angioedema.
    E.1.1.1Medical condition in easily understood language
    Symptoms or signs such as swelling or pain at any location.
    Síntomas o indicios como edema o dolor en cualquier lugar.
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019860
    E.1.2Term Hereditary angioedema
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    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 efficacy of two doses of CINRYZE with rHuPH20 administered by SC injection to prevent HAE attacks.
    To assess the safety and tolerability of two doses of CINRYZE with rHuPH20 administered by SC injection.
    Evaluar la eficacia de dos dosis de CINRYZE con rHuPH20 administradas por inyección SC para prevenir las crisis de AEH.
    Evaluar la seguridad y la tolerabilidad de dos dosis de CINRYZE con rHuPH20 administradas por inyección SC.
    E.2.2Secondary objectives of the trial
    To determine the optimal dose of CINRYZE with rHuPH20 administered by SC injection for prevention of angioedema attacks based upon benefit-risk assessment.
    To further characterize the PK and PD of CINRYZE with rHuPH20 administered by SC injection.
    To assess the immunogenicity of CINRYZE with rHuPH20 following SC administration.
    To assess subject acceptance of SC administration of CINRYZE with rHuPH20 for prevention of angioedema attacks.
    To assess health status (quality of life) of this patient population.
    Determinar la dosis óptima de CINRYZE con rHuPH20 administrado por inyección SC para la prevención de las crisis de angioedema basándose en la valoración de la relación beneficio-riesgo.
    Definir mejor la FC y la FD de CINRYZE con rHuPH20 administrado mediante inyección SC.
    Valorar la inmunogenicidad de CINRYZE con rHuPH20 tras la administración SC.
    Valorar la aceptación de los sujetos a la administración SC de CINRYZE con rHuPH20 para la prevención de las crisis de angioedema.
    Valorar el estado de salud (calidad de vida) de esta población de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for this protocol, a subject must:
    Be >=12 years of age.
    Have a confirmed diagnosis of HAE with a history of at least one of the following:
    C1 INH antigen level below normal; Functional C1 INH level below normal; If currently receiving prophylactic IV CINRYZE therapy (i.e., 1000 U every 3 or days or up to 2000 U per week), have: during the 3 consecutive months prior to randomization, an HAE attack rate of <=1.0 moderate or severe attack per month (average). During the 3 consecutive months prior to starting prophylactic IV CINRYZE therapy, a history of at least 2.0 moderate or severe HAE attacks per month (average).
    If not on prophylactic IV CINRYZE therapy, have a history of at least 2.0
    moderate or severe HAE attacks per month (average) during the 3 consecutive
    months prior to randomization.
    Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.
    Agree to adhere to the protocol-defined schedule of assessments and procedures. If female, be post-menopausal (cessation of menses greater than or equal to 1 year), surgically sterile, or following an acceptable non-hormonal method of birth control such as intrauterine device or barrier control for at least 1 complete menstrual cycle before the screening visit and agree to continue use through the 30-day post-treatment visit, or using hormonal birth control products for at least 3 months prior to the first dose of study drug in Treatment Period 1 and agree to continue use through the 30-day post-treatment visit. If male, be surgically sterile or agree to follow an acceptable method of birth control (e.g., barrier control) from the screening visit through 2 months after the last dose of study drug. If an adult (>=18 years of age), be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
    If a child (<18 years of age), have a parent(s)/legal guardian who is informed of the nature of the study provide written informed consent for the child to participate in the study before any study-specific procedures are performed (with assent from the child when appropriate). Alternatively, certain sites/IRAs may permit adolescents who are <18 years of age to be informed of the nature of the study and provide written informed consent without consent from a parent(s)/legal guardian.
    Para poder participar en este protocolo, los sujetos deberán:
    1. Tener >= 12 años de edad.
    2. Tener un diagnóstico confirmado de AEH con al menos uno de los antecedentes siguientes:
    - Concentración de antígeno del INH C1 inferior a la normal
    - Concentración del INH C1 funcional inferior a la normal
    3. Si están recibiendo actualmente tratamiento profiláctico con CINRYZE IV (es decir, 1000 U cada 3 ó 4 días o hasta 2000 U a la semana), deben tener:
    - durante los 3 meses consecutivos previos a la aleatorización, una tasa de crisis de AEH de <= 1,0 crisis moderadas1 o intensas2 al mes (en promedio).
    Y
    - durante los 3 meses consecutivos previos al inicio del tratamiento profiláctico IV con CINRYZE, tener antecedente de al menos 2,0 crisis de AEH moderadas1 o intensas2 al mes (en promedio).
    4. Si no están recibiendo tratamiento profiláctico intravenoso con CINRYZE, tener antecedentes de al menos 2,0 crisis de AEH moderadas o intensas al mes (en promedio) durante los 3 meses consecutivos previos a la aleatorización.
    5. Comprometerse a evitar en lo posible sus desencadenantes conocidos de AEH durante el estudio.
    6. Comprometerse a cumplir el calendario de valoraciones y procedimientos definido en el protocolo.
    7. Si son mujeres, ser posmenopáusicas (sin menstruación durante 1 año o más), estar esterilizadas quirúrgicamente o seguir un método anticonceptivo no hormonal aceptable, como un dispositivo intrauterino o método de barrera, durante al menos un ciclo menstrual completo antes de la visita de selección y comprometerse a seguir utilizándolo hasta 30 días después del tratamiento, o haber empleado productos anticonceptivos hormonales durante al menos 3 meses antes de la primera dosis del fármaco del estudio en el periodo de tratamiento 1 y comprometerse a seguir utilizándolos hasta 30 días después del tratamiento.
    8. Si son varones, estar esterilizados quirúrgicamente o comprometerse a seguir un método anticonceptivo aceptable (p. ej., de barrera) desde la visita de selección hasta 2 meses después de la última dosis del fármaco del estudio.
    9. Si son adultos (>= 18 años), estar informados de la naturaleza del estudio y dar su consentimiento informado por escrito antes de que se realice cualquier procedimiento específico del estudio.
    O
    Si son niños (<18 años), que un padre o tutor legal que esté informado de la naturaleza del estudio dé el consentimiento informado por escrito para que el niño participe en el estudio antes de que se realice cualquier procedimiento específico del estudio (con asentimiento del niño cuando proceda). Por otro lado, algunos centros u ORI pueden permitir que se informe a adolescentes de <18 años de edad de la naturaleza del estudio y den su consentimiento informado por escrito sin el consentimiento de un padre o tutor legal.
    E.4Principal exclusion criteria
    To be eligible for this protocol, a subject must not:
    Have received any C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 7 days prior to the first dose of study drug in Treatment Period 1.
    Be receiving prophylactic IV CINRYZE that exceeds the approved dosing regimen of 1000 U every 3 or 4 days (maximum weekly dose of 2000 U).
    Have had HAE attack signs or symptoms within 2 days prior to the first dose of study drug in Treatment Period 1.
    Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug in Treatment Period 1.
    If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug in Treatment Period 1.
    Have a history of hypercoagulability (abnormal blood clotting).
    Have a history of allergic reaction to C1 INH products, including CINRYZE (or any components of CINRYZE), or other blood products.
    Have a known allergy to hyaluronidase or any other ingredient in the study formulation.
    Be pregnant or breastfeeding.
    Have received an investigational study drug within 30 days prior to the first dose of study drug in Treatment Period 1.
    Have, as determined by the Investigator and/or the Sponsor?s medical monitor, any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results.
    Para poder participar en este protocolo, los sujetos no deberán:
    1. Haber recibido cualquier tratamiento con INH C1 o hemoderivados para el tratamiento o la prevención de una crisis de AH en los 7 días previos a la primera dosis del fármaco del estudio en el periodo de tratamiento 1.
    2. Estar recibiendo CINRYZE IV profiláctico en cantidad superior a la pauta posológica aprobada de 1000 U cada 3 ó 4 días (dosis semanal máxima de 2000 U).
    3. Haber tenido signos o síntomas de crisis de AEH en los 2 días previos a la primera dosis del fármaco del estudio en el periodo de tratamiento 1.
    4. Presentar cualquier cambio (inicio, interrupción o cambio de dosis) de un tratamiento con andrógenos (p. ej., danazol, oxandrolona, estanozolol, testosterona) en los 14 días previos a la primera dosis del fármaco del estudio en el periodo de tratamiento 1.
    5. Si son mujeres, haber empezado a tomar o cambiado la dosis de cualquier régimen anticonceptivo hormonal o tratamiento hormonal sustitutivo (es decir, productos que contengan estrógenos/progestágeno) en los 3 meses previos a la primera dosis del fármaco del estudio en el periodo de tratamiento 1.
    6. Tener antecedentes de hipercoagulabilidad (coagulación anormal de la sangre).
    7. Tener antecedentes de reacción alérgica a productos con INH C1, incluido CINRYZE (o a cualquier componente de CINRYZE), u otros hemoderivados.
    8. Tener alergia conocida a la hialuronidasa o a cualquier otro componente de la formulación en estudio.
    9. Estar embarazadas o practicar la lactancia materna.
    10. Haber recibido un fármaco en investigación en los 30 días previos a la primera dosis del fármaco del estudio en el periodo de tratamiento 1.
    11. Tener, según lo determinado por el investigador o el monitor médico del promotor, cualquier proceso quirúrgico o médico que pueda interferir en la administración del fármaco del estudio o en la interpretación de los resultados del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the number of angioedema attacks recorded during each treatment period, normalized for the number of days the subject participated in that period.
    El criterio principal de valoración de la eficacia es el número de crisis de angioedema registradas durante cada periodo de tratamiento, normalizada para el número de días que el sujeto participó en ese período.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the treatment period.
    Final del periodo de tratamiento.
    E.5.2Secondary end point(s)
    Response status (i.e., Responder/Non-Responder) during each active treatment period. This endpoint is exploratory in that several definitions of response will be evaluated. These definitions will incorporate attributes of a subject?s HAE attacks including:
    - Changes in attack rates (either absolute or relative).
    - Anatomic location.
    - Severity of pain as measured by a VAS.
    - Duration (in days).
    Time (measured in days from the first dose of study drug in a treatment period) to the first HAE attack during each treatment period.
    El estado de respuesta (es decir, con/sin respuesta) durante cada período de tratamiento activo. Este criterio de valoración es exploratorio, ya que se evaluarán varias definiciones de respuesta. Estas definiciones incorporarán características de las crisis de AEH de un sujeto como:
    - Los cambios de las tasas de crisis (absolutos o relativos).
    - La localización anatómica.
    - La intensidad del dolor medida mediante una EAV.
    - La duración (en días).
    - El tiempo (medido en días desde la primera dosis del fármaco del estudio en un período de tratamiento) hasta la primera crisis de AEH durante cada período de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the treatment period.
    Final del periodo de tratamiento.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    dosis diferentes del mismo producto.
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 No
    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 last subject.
    Última visita del 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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 Yes
    F.1.1Number of subjects for this age range: 5
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    A post-treatment visit will be performed at the investigative site 1 week after the last dose of study drug in Treatment Period 2 for follow-up safety assessments. Subjects must report to the investigational site for the 1-week post-treatment visit. In addition, subjects will have a blood sample for C1 INH and rHuPH20 antibody testing collected 30 days after the last dose of study drug.
    Habrá una visita postratamiento en el centro investigador 1 semana después de la última dosis del fármaco del estudio en el periodo de tratamiento 2 para realizar valoraciones de la seguridad de seguimiento. Los sujetos deberán acudirán al centro de investigación para la visita 1 semana después del tratamiento. Además, se obtendrá de los sujetos una muestra de sangre para análisis de anticuerpos contra INH C1 y rHuPH20 30 días después de la última dosis del fármaco del estudio.
    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 Decision2012-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-23
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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