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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41201   clinical trials with a EudraCT protocol, of which   6744   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    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:2014-004261-24
    Sponsor's Protocol Code Number:CL006_168
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-09-25
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-004261-24
    A.3Full title of the trial
    AN OPEN-LABEL PHASE 2 STUDY TO ASSESS THE EFFECT OF C5AR ANTAGONIST THERAPY BY CCX168 ORAL ADMINISTRATION ON EX VIVO THROMBUS FORMATION AND DISEASE ACTIVITY IN ESRD PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (ACCESS Study)
    AN OPEN-LABEL PHASE 2 STUDY TO ASSESS THE EFFECT OF C5AR ANTAGONIST THERAPY BY CCX168 ORAL ADMINISTRATION ON EX VIVO THROMBUS FORMATION AND DISEASE ACTIVITY IN ESRD PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (ACCESS Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROPOSAL OF STUDY TO DETERMINE IF THE ORAL ADMINISTRATION OF CCX168 INHIBITS THE ACTIVITY 'COMPLEMENT AND THE FORMATION OF CLOTS IN PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME IN DIALYSIS
    PROPOSTA DI STUDIO PER DETERMINARE SE LA SOMMINISTRAZIONE ORALE DI CCX168 INIBISCE L’ATTIVITÀ’ DEL COMPLEMENTO E LA FORMAZIONE DI TROMBI IN PAZIENTI CON SINDROME EMOLITICO UREMICA ATIPICA IN DIALISI
    A.3.2Name or abbreviated title of the trial where available
    Complement inhibition in aHUS dialysis patients
    Inibizione del complemento in pazienti dializzati affetti da Sindrome Emolitico Uremica atipica
    A.4.1Sponsor's protocol code numberCL006_168
    A.5.4Other Identifiers
    Name:ACCESSNumber:CL006_168
    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 SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    B.1.3.4CountryItaly
    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 supportIstituto di Ricerche Farmacologiche Mario Negri
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportChemoCentryx, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto di Ricerche Farmacologiche Mario Negri - Centro Daccò
    B.5.2Functional name of contact pointLab. Attività Regolatorie relative
    B.5.3 Address:
    B.5.3.1Street Addressvia G. Camozzi, 3
    B.5.3.2Town/ cityRanica BG
    B.5.3.3Post code24020
    B.5.3.4CountryItaly
    B.5.4Telephone number0354535307
    B.5.5Fax number0354535371
    B.5.6E-mailpaola.boccardo@marionegri.it
    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 nameCCX168
    D.3.2Product code CCX168
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCCX168
    D.3.9.4EV Substance CodeSUb168685
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atypical Hemolytic Uremic Syndrome
    Sindrome Emolitico Uremica atipica
    E.1.1.1Medical condition in easily understood language
    Atypical Hemolytic Uremic Syndrome
    Sindrome Emolitico Uremica atipica
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019515
    E.1.2Term Hemolytic uremic syndrome
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether in vivo CCX168 treatment dampens the ex vivo prothrombogenic properties of
    serum from ten chronic dialysis patients with aHUS on cultured microvascular endothelial cells.
    Valutare, su cellule endoteliali del microcircolo in coltura, se il trattamento in vivo con CCX168
    determina una diminuzione delle proprietà protrombogeniche del siero derivante da 10 pazienti affetti da SEU atipica in trattamento dialitico cronico.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of in vivo CCX168 treatment on:
    i. Biomarkers of complement and disease activity
    ii. Clinical parameters including pre-dialysis and intradialytic
    blood pressure and heart rate
    iii. Safety and tolerability parameters
    iv. Patient health-related quality of life
    v. CCX168 pharmacokinetic (PK) profile.
    Valutare gli effetti in vivo del trattamento con CCX168 su:
    i. Biomarkers dell’attività del complemento e della malattia comprendenti:
    - Depositi ex vivo di C5b-9 sulle cellule endoteliali del microcircolo;
    - Livelli sierici di C3, C4 e C5;
    - Attività totale residua del complemento CH50;
    - CFH, SC5b-9, Bb, e C5a su plasma raccolto su EDTA;
    - Trombomodulina solubile, VCAM-1 sierico, TNF alfa, prodotti dello split della fibrina;
    - Livelli sierici di LDH, conta piastrinica, conta dei neutrofili, valori di emoglobina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >18 years;
    - Diagnosis of aHUS with or without identified genetic abnormalities in the complement system or
    thrombomodulin;
    - Stable chronic extracorporeal or peritoneal dialysis therapy since at least 6 months;
    - Written informed consent.
    - Età >18 anni;
    - Diagnosi di SEU atipica in presenza o in assenza di anomalie genetiche del sistema del complemento o della trombomodulina;
    - Trattamento dialitico extracorporeo o peritoneale cronico stabile da almeno 6 mesi;
    - Consenso informato scritto.
    E.4Principal exclusion criteria
    - Women of childbearing potential or women who are breastfeeding;
    - Shiga toxin-associated HUS or secondary forms of thrombotic microangiopathy;
    - ADAMTS13 activity <10 % or circulating anti ADAMTS13 autoantibodies consistent with the
    diagnosis of thrombotic thrombocytopenic purpura;
    - Need for specific intervention with plasma therapy and/or complement inhibitors as deemed clinically appropriate;
    - Plasma therapy or treatment with complement inhibitors or antiplatelet and antithrombotic agents
    over the last two weeks;
    - Liver function impairment (serum liver enzymes or bilirubin levels >3 x upper limit of normal);
    - Neutrophil count < 2000/μL or lymphocyte count < 1000/μL;
    - Infection requiring antibiotic treatment within the previous 4 weeks prior to screening;
    - Participated in any clinical study of an investigational product within 30 days prior to screening or within 5 half-lives after taking the last dose;
    - History or presence of any medical condition or disease which, in the opinion of the Investigator
    may place the subject at unacceptable risk for study participation;
    - Inability to understand the potential risks and benefits of the study;
    - Legal incapacity.
    - Donne potenzialmente fertili o in allattamento;
    - SEU Stx-associata o forme secondarie di microangiopatia trombotica;
    - Attività di ADAMTS13 <10 % o presenza di auto anticorpi circolanti anti ADAMTS13 consistente con la diagnosi di TTP;
    - Necessità di terapia plasmatica e/o terapia con inibitori del complemento;
    - Terapia plasmatica o trattamento con inibitori del complemento o agenti antipiastrinici e
    antitrombotici nelle due settimane precedenti;
    - Insufficienza epatica (enzimi epatici o livelli di bilirubina superiori di più di tre volte del
    valore di normalità superiore);
    - Numero di neutrofili < 2000/μL o numero di linfociti < 1000/μL;
    - Infezioni che abbiano richiesto il trattamento con antibiotici nelle 4 settimane precedenti lo screening;
    - Partecipazione ad uno studio clinico interventistico nei 30 giorni precedenti lo screening o nel periodo corrispondente a 5 emivite del farmaco a partire dall’ultima dose assunta;
    - Storia o presenza di qualsiasi condizione clinica o patologia che, a giudizio dello sperimentatore, esponga il paziente ad un rischio inaccettabile in caso di partecipazione allo studio;
    - Incapacità di comprendere i potenziali rischi e benefici dello studio;
    - Incapacità legale.
    E.5 End points
    E.5.1Primary end point(s)
    Ex vivo thrombogenesis.
    Trombogenesi ex vivo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0, 3, 14,16 and 21.
    Giorno 0, 3, 14,16 e 21.
    E.5.2Secondary end point(s)
    Patient health-related quality of life.
    Valutazione della qualità di vita del paziente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, 14 and 21.
    Giorno 0, 14 e 21.
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS
    LVLS
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 1
    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.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    The subjects will be administered with the best treatment available.
    I soggetti verranno seguiti con la miglior terapia disponibile.
    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 Decision2015-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-02-24
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA