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    Summary
    EudraCT Number:2007-001661-15
    Sponsor's Protocol Code Number:087-CL-089
    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:2007-09-12
    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 number2007-001661-15
    A.3Full title of the trial
    A Phase 2, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Assess the Safety and Effects of Intravenous Conivaptan on the Hepatic Hemodynamic Response in Stable Euvolemic or Hypervolemic Cirrhotic Patients

    Estudio fase II, randomizado, doble ciego, controlado con placebo, de escalonamiento de dosis para evaluar la seguridad y los efectos de Conivaptan intravenoso sobre la respuesta hemodinámica hepática en pacientes cirróticos euvolémicos o hipervolémicos estables.
    A.4.1Sponsor's protocol code number087-CL-089
    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 SponsorAstellas Pharma US, Inc
    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 Yes
    D.2.1.1.1Trade name Vaprisol
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas PharmaUS, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameconivaptan hydrochloride injection
    D.3.2Product code YM087
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNconivaptan hydrochloride injection
    D.3.9.2Current sponsor codeYM087
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.3.11.8Extractive medicinal product No
    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 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 placeboIntravenous 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
    stable euvolemic or hypervolemic cirrhotic patients with serum sodium 115 – 140 mEq/L

    Pacientes cirróticos euvolémicos o hipervolémicos estables con un valor de sodio sérico comprendido entre 115 y 140 mEq/L
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10019641
    E.1.2Term Hepatic cirrhosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10021038
    E.1.2Term Hyponatremia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the safety of two different doses of IV conivaptan (YM087 or Vaprisol®) in stable euvolemic or hypervolemic cirrhotic patients with serum sodium 115 – 140 mEq/L and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis.

    Evaluar la seguridad de dos dosis diferentes de conivaptán i.v. (YM087 o Vaprisol®) en pacientes cirróticos euvolémicos o hipervolémicos estables con un valor de sodio sérico comprendido entre 115 y 140 mEq/L y caracterizar los efectos de conivaptán i.v. sobre la respuesta hemodinámica hepática en pacientes con cirrosis.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and appropriate privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    -Males or females greater than or equal to 18 years of age.
    -Female subjects of child bearing potential must have a negative serum β-HCG pregnancy test during the screening or baseline period (must be postmenopausal, surgically sterile or must practice a method of birth control considered suitable by the investigator, even if taking hormone contraceptives).
    -Subject has a serum sodium value between 115 and 140 mEq/L prior to 24 hours of study drug administration.
    -Subject is euvolemic or is hypervolemic (edematous) secondary to cirrhosis.
    -Subject has clinical evidence of portal hypertension by the presence of esophageal varices, ascites or both.

    - Debe obtenerse el Consentimiento Informado aprobado por el Consejo Institucional de Revisión (IRB)/Comité Ético de Investigación Clínica (CEIC) por escrito del paciente o representante legalmente autorizado antes de realizar ningún procedimiento relacionado con el estudio (incluida la interrupción de las medicaciones prohibidas, si procede). El consentimiento informado es el aprobado por el Consejo Institucional de Revisión (IRB)/Comité Ético de Investigación Clínica (CEIC) de acuerdo con la legislación vigente de estudios clínicos en España, el R.D. 223/2004, de 6 de febrero.
    - Hombres o mujeres de edad igual o superior a 18 años.
    - En las mujeres en edad fértil, el resultado de la prueba de embarazo con -HCG sérica debe ser negativo durante el periodo de selección y la visita basal del estudio (pueden ser postmenopáusicas, haber sufrido un procedimiento de esterilización quirúrgica o seguir un método de control de la natalidad que el investigador considere adecuado, incluso si toman los anticonceptivos hormonales).
    - Pacientes con un valor de sodio sérico comprendido entre 115 y 140 mEq/L antes de las 24 horas de administración del fármaco de estudio.
    - Pacientes con euvolemia o hipervolemia (edematosos) secundaria a la cirrosis.
    - Pacientes con evidencia clínica de hipertensión portal por la presencia de varices esofágicas, ascitis o ambas.
    E.4Principal exclusion criteria
    -Female subject is pregnant or lactating.
    -Clinical evidence of volume depletion or dehydration.
    -Expected requirement for emergent treatment of hyponatremia during the course of the study.
    -Participation in another clinical trial of an investigational drug (including placebo) or device within 30 days of screening for entry into the present study.
    -Subject has a hepatic encephalopathy or fulminant hepatic failure.
    -Subject has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma using the Milan criteria (no evidence of extrahepatic tumor and unifocal tumor mass < 5 cm in diameter or multifocal tumors < 4 in number, each < 3 cm in diameter; [Mazzaferro V et al, 1996]) and basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully.
    -Subject has a history of bleeding from esophageal varices within three months before the start of the study.

    - Mujeres embarazadas o en periodo de lactancia.
    - Evidencia clínica de depleción de volumen o deshidratación.
    - Expectativas de que se necesite tratamiento de urgencia para la hiponatremia durante el estudio.
    - Participación en otro ensayo clínico de un fármaco en investigación (incluido placebo) o de un dispositivo en los 30 días previos a la visita de selección para participar en este estudio.
    - Pacientes con encefalopatía hepática o insuficiencia hepática fulminante.
    - Paciente con patología maligna previa (en los últimos 5 años) o actual, excepto en el caso de carcinoma hepatocelular utilizando los criterios de Milán (sin evidencia de tumor extrahepático y una masa tumoral unifocal < 5cm de diámetro o < 4 tumores multifocales cada uno de < 3cm de diámetro [Mazzaferro V et al, 1996]) y del carcinoma cutáneo de células escamosas basal o no metastásico que haya sido tratado de forma eficaz.
    - Pacientes con antecedentes de sangrado de varices esofágicas en los tres meses previos al inicio del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    -Change in portal pressure as estimated by the hepatic venous pressure gradient (HVPG) from Baseline to the 1.5 hour time point.
    -Change in hepatic blood flow (HBF) from Baseline to the 1.5 hour time point.
    -Change in mean arterial pressure (MAP) from Baseline to the 1.5 hour time point.
    -Change from Baseline in heart rate and blood pressure at 1.5, 6.5 and 24 hours.
    -Change from Baseline in HVPG, HBF and MAP at 0.5, 1 and 1.5 hours.
    -Change from Baseline in heart rate and blood pressure at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, 24 hours and Day 8.
    -Change in serum sodium from Baseline to the 6.5 and 24 hour time points.
    -Change from Baseline in serum sodium at 0.5, 1, 2.5, 4, 6.5, 9, 12, 24 hours and Day 8.
    -In addition, the following measurements will be collected to evaluate the safety of each dosing regimen: vital signs, physical exam, ECG, laboratory measurements, urinalysis and adverse events.

    - Cambio desde el valor basal hasta el punto temporal de 1,5 horas en la presión portal estimada por el gradiente de presión venosa hepática (GPVH).
    - Cambio desde el valor basal hasta el punto temporal de 1,5 horas en el flujo sanguíneo hepático (FSH).
    - Cambio desde el valor basal hasta el punto temporal de 1,5 horas en la tensión arterial media (TAM).
    - Cambio desde el valor basal hasta los puntos temporales 1,5, 6,5 y 24 horas en la frecuencia cardiaca y la tensión arterial.
    - Cambio desde el valor basal hasta los puntos temporales 0,5, 1 y 1,5 horas de la GPVH, FSH y TAM.
    - Cambio desde el valor basal hasta los puntos temporales 0,5, 1, 1,5, 2,5, 3,5, 4,5, 5,5, 6,5, 9, 12, 24 horas y 8 días en la frecuencia cardiaca y la tensión arterial.
    - Cambio desde el valor basal hasta los puntos temporales 6,5 y 24 horas en el nivel de sodio sérico.
    - Cambio desde el valor basal hasta los puntos temporales 0,5, 1, 2,5, 4, 6,5, 9, 12, 24 horas y 8 días en el nivel de sodio sérico.
    - Además, se registrarán las siguiente valoraciones para evaluar la seguridad de cada dosis: constantes vitales, exploración física, ECG, análisis de laboratorio, análisis de orina y acontecimientos adversos.
    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 No
    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 Information not present in EudraCT
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    sequential dose escalation
    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 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 Information not present in EudraCT
    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
    The end of the study is defined as the date the last subject's last protocol-defined assessment is completed.

    El final del estudio se define como la fecha de la última evaluación del último paciente definida por protocolo.
    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 months0
    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 months0
    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 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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-09-12. Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2007-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-06
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