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   43845   clinical trials with a EudraCT protocol, of which   7282   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:2011-004304-38
    Sponsor's Protocol Code Number:12011.203
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-22
    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 number2011-004304-38
    A.3Full title of the trial
    A long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy
    Estudio de seguimiento de la seguridad a largo plazo de la terapia con L-CsA para pacientes que participaron en el estudio 12011.201 y se prestaron voluntarios para continuar o pasarse a la terapia de inhalación con L-CsA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA
    Estudio de seguimiento de la seguridad a largo plazo de la terapia con L-CsA para pacientes que participaron en el estudio 12011.201 y se prestaron voluntarios para continuar o pasarse a la terapia de inhalación con L-CsA
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code number12011.203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01439958
    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 SponsorPARI Pharma GmbH
    B.1.3.4CountryGermany
    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 supportPARI Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPARI Pharma
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressLochhamer Schlag 21
    B.5.3.2Town/ cityGraefelfing
    B.5.3.3Post code82166
    B.5.3.4CountryGermany
    B.5.4Telephone number4989742846830
    B.5.5Fax number498974284630
    B.5.6E-mailS.Prante@PARI.DE
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3//04/210
    D.3 Description of the IMP
    D.3.1Product nameAerolised Liposomal Ciclosporin A 5mg
    D.3.2Product code L-CsA
    D.3.4Pharmaceutical form Powder for nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiclosporin
    D.3.9.1CAS number 59856-13-3
    D.3.9.2Current sponsor code081400
    D.3.9.3Other descriptive nameCiclosporine, Ciclosporina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) 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 Yes
    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.IMP: 2
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3//04/210
    D.3 Description of the IMP
    D.3.1Product nameAerolised Liposomal Ciclosporin A 10mg
    D.3.2Product code L-CsA
    D.3.4Pharmaceutical form Powder for nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiclosporin
    D.3.9.1CAS number 59856-13-3
    D.3.9.2Current sponsor code081400
    D.3.9.3Other descriptive nameCiclosporine, Ciclosporina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) 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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
    Prevención del síndrome de bronquiolitis obliterante en pacientes con trasplante pulmonar
    E.1.1.1Medical condition in easily understood language
    Prevention of the destruction of lung tissue after a lung transplant
    Prevención del síndrome de bronquiolitis obliterante en pacientes con trasplante pulmonar
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049202
    E.1.2Term Bronchiolitis obliterans
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to evaluate the long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201.
    Evaluar la seguridad a largo plazo de L-CsA en la prevención del síndrome de bronquiolitis obliterante (SBO) tras un trasplante de pulmón (TP) en pacientes previamente incluidos en el ensayo clínico de fase II/III con L-CsA, 12011.201
    E.2.2Secondary objectives of the trial
    In addition, the long-term efficacy outcome over a maximum of three years will be determined.
    Determinar el resultado de eficacia a largo plazo durante un máximo de tres años
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient has completed the L-CsA clinical trial 12011.201
    2.Patient is capable of understanding the purpose and risks of the follow-up study, has been fully informed and has given written informed consent to participate in the study
    3.Female patients of child bearing potential must test negative on standard urine pregnancy test prior to continuation and must agree to practice effective birth control during the study(see Appendix 3)
    4.Estimated life expectancy > 6 months
    5.Capable of self-administration of medications
    6.Patient has stable creatinine levels
    Criterios de inclusión
    1.El paciente ha completado el ensayo clínico 12011.201 con L-CsA
    2.El paciente es capaz de entender el objetivo y los riesgos del estudio de seguimiento, ha sido completamente informado y ha otorgado su consentimiento informado por escrito para participar en el estudio
    3.Las mujeres en edad fértil deben obtener un resultado negativo en una prueba de embarazo estándar en orina antes de continuar y deben aceptar utilizar anticonceptivos eficaces durante el estudio (ver Anexo 3)
    4.Esperanza de vida estimada >6 meses
    5.Capaz de autoadministrarse los medicamentos
    6.El paciente tiene niveles de creatinina estables
    E.4Principal exclusion criteria
    1.Patients with ongoing irreversible L-CsA related serious adverse events
    2.Patients with known hypersensitivity for ciclosporin A
    3.Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria
    4.Patient receives mechanical ventilation
    5.Patients underwent pulmonary re-transplantation
    6.Patient is a pregnant or breast-feeding woman
    7.Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
    8.Patient receives any systemic or topical Rosuvastatin
    9.Patient has been previously enrolled in this study
    10.Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer)
    11.Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response
    12.Patient is not eligible to continue IMP inhalation according to the Investigator?s discretion
    1.Pacientes con acontecimientos adversos graves en curso e irreversibles asociados a la L-CsA
    2.Pacientes con hipersensibilidad conocida a la ciclosporina A
    3.Paciente con intención de participar en otro ensayo clínico con un PEI a excepción de los enumerados en los criterios de inclusión
    4.Paciente recibe ventilación mecánica
    5.Pacientes sometidos a retrasplante de pulmón
    6.Paciente embarazada o en periodo de lactancia
    7.Paciente con poca probabilidad de cumplir con las visitas, los procedimientos de inhalación o las determinaciones espirométricas previstos en el protocolo
    8.Paciente recibe rosuvastatina sistémica o tópica
    9.Paciente previamente incluido en este estudio
    10.Paciente con una neoplasia maligna diagnosticada durante el estudio 12011.201 (a excepción de cáncer de piel)
    11.Infecciones respiratorias documentadas, a menos que reciba tratamiento antimicrobiano apropiado y muestre indicios de una respuesta clínica
    12.Paciente no elegible para continuar con la inhalación del PEI a juicio del investigador
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints:
    Safety will be assessed using the following parameters:
    ?Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (from inclusion into the 12011 203 study)
    ?Laboratory evaluations (chemistry, haematology and urinalysis) will be performed as scheduled by the local institution. Only abnormal and clinically relevant values will be recorded when they are reported
    ?Overall rate of mortality
    ?Vital signs
    ?Trough L-CsA and tacrolimus blood levels
    Criterios de valoración de la seguridad:
    La seguridad se evaluará utilizando los siguientes parámetros:
    Acontecimientos adversos (AA) y acontecimientos adversos graves (AAG) emergentes del tratamiento
    ?Se realizarán evaluaciones de laboratorio (bioquímica, hematología y urinálisis) de la forma prevista por el centro local. Solo se registrarán los valores anormales y clínicamente relevantes cuando se notifiquen
    ?Tasa global de mortalidad
    ?Constantes vitales
    ?Niveles mínimos de L-CsA y tacrolimus en sangre
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety end-points will be evaluated throught the duration of the study.
    Los criterios de valoración de la seguridad se evaluarán durante la duración del estudio.
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    Bronchiolitis obliterans syndrome (BOS):
    ?BOS-free survival
    ?Incidence of BOS
    ?Pulmonary function
    Criterios de valoración de la eficacia:
    Síndrome de bronquiolitis obliterante (SBO):
    ?Supervivencia libre de SBO
    ?Incidencia de SBO
    ?Función pulmonar
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy will be assessed using the following parameters:
    ?Time to occurrence of BOS (? grade 1), respectively BOS progression over the following time period
    ?Period of time starting from inclusion into study 12011.201 (Phase II/III) until occurrence of BOS ? grade 1, or death, or re-transplantation
    Incidence of BOS (until end of study):
    ?Number and severity of BOS episodes from inclusion until end of study 12011.203 (Safety follow-up)
    Pulmonary Function Tests (PFT) (at each clinic visit):
    ?Forced Expiratory Volume in one second (FEV1).
    ?Forced Midexpiratory Flow (FEF25-75)
    Se evaluará la eficacia utilizando los siguientes parámetros:
    Tiempo hasta la aparición de SBO (? grado 1) y progresión de SBO durante el siguiente periodo de tiempo, respectivamente
    ?Periodo de tiempo desde la inclusión en el estudio 12011.201 (fase II/III) hasta la aparición de SBO ? grado 1, o muerte, o retrasplante
    Incidencia de SBO (hasta finalizar el estudio):
    ?Número y severidad de los episodios de SBO desde la inclusión hasta finalizar el estudio 12011.203 (seguimiento de seguridad)
    Pruebas de la función pulmonar (PFP) (en cada visita al centro):
    ?Volumen espiratorio forzado en un segundo (VEF1).
    ?Flujo mesoespiratorio forzado (FEF25-75)
    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 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Yes
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Canada
    Denmark
    France
    Germany
    Spain
    United Kingdom
    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 Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 180
    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)
    Patients will revert to standard of care
    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 Decision2012-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    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-Thu Apr 18 10:37:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA