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    Summary
    EudraCT Number:2013-003207-19
    Sponsor's Protocol Code Number:PLD11-01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003207-19
    A.3Full title of the trial
    An international, multicenter, randomized controlled clinical trial assessing the efficacy of Ursodeoxycholic acid as a volume reducing treatment for symptomatic polycystic livers
    Een internationale, multicenter gerandomiseerde gecontroleerde klinische trial naar het effect van ursodeoxycholzuur op het reduceren van levervolume als behandeling in patienten met symptomatisch polycysteuze leverziekte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to investigate the effect of ursodeoxycholic acid as a treatment of symptoms in polycystic liver disease: the CURSOR-trial
    Onderzoek naar de werkzaamheid van Ursochol als behandeling van klachten in polycysteuze leverziekte: De CURSOR-studie.
    A.3.2Name or abbreviated title of the trial where available
    The CURSOR trial
    De CURSOR-studie
    A.4.1Sponsor's protocol code numberPLD11-01
    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 SponsorRadboud University Nijmegen Medical Center
    B.1.3.4CountryNetherlands
    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 supportRadboud University Medical Center Nijmegen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Nijmegen Medical Center
    B.5.2Functional name of contact pointDep.of Gastroenterology&Hepatology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 8
    B.5.3.2Town/ citynijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310243619190
    B.5.5Fax number00310243540103
    B.5.6E-mailjoostphdrenth@cs.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 URSOCHOL 300 URSOCHOL 450
    D.2.1.1.2Name of the Marketing Authorisation holderZambon B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Pillules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    Oral use
    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 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
    Patients suffering from symptomatic polycystic liver disease (PLD) with underlying diagnosis of isolated polycystic liver disease (PCLD) or autosomal dominant kidney disease (ADPKD)
    E.1.1.1Medical condition in easily understood language
    liver cysts as a consequence of plycystic liver disease or as a consequence of heritable kidney cyst
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    First, to demonstrate whether UDCA-therapy is effective in reducing total liver volume in PLD patients.
    E.2.2Secondary objectives of the trial
    Second, we want to assess if UDCA modifies quality of life. Finally, we want to assess safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18 ≤ age ≤ 80 years
    • Polycystic liver disease with underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts
    • Total liver volume ≥ 2500 mL
    • Symptomatic defined as ECOG-PS ≥ 1, and having at least three out of ten PCLD symptoms:
    - Abdominal pain
    - Abdominal distension
    - Abdominal fullness
    - Dyspnea
    - Early satiety
    - Back pain
    - Nausea/vomiting
    - Anorexia
    - Weight loss
    - Jaundice
    • Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.
    E.4Principal exclusion criteria
    • Use of oral anticonceptives or estrogen supplementation
    • Use of UDCA in 3 months before baseline
    • Females who are pregnant or breast-feeding or patients of reproductive potential not employing an effective method of birth control.
    • Intervention (aspiration or surgical intervention) within six months before baseline
    • Treatment with somatostatin analogues within months before baseline
    • Renal dysfunction (MDRD-GFR < 30 ml/min/1.73m2)
    • Patients with a kidney transplant
    • Hypersensitivity reaction to UDCA or patients with galactose-intolerance, lactase deficiency or glucose-galactose malabsorption
    • Acute cholecystitis or frequent biliary colic attacks
    • Acute stomach or duodenal ulcers
    • Inflammation of small intestine or colon
    • Use of drugs that can interact with UDCA, such as colestyramine or aluminium hydroxide
    • Enrolment in another clinical trial of an investigational agent while participating in this study
    • History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
    • Mental illness that interferes with the patient ability to comply with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome measure will be the proportional change of total liver volume from baseline to 6 months as determined by CT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline liver volume will be compared to liver volume at 24 weeks.
    E.5.2Secondary end point(s)
    • Change in absolute total liver volume
    • Change in symptoms, measured by GI-questionnaire
    • Change in quality of life, measured by SF-36 questionnaire
    • Proportion of patients having any reduction in total liver volume after 24 weeks
    • (Serious )Adverse events that occur in these 24 weeks
    • TKV at baseline and after 24 weeks

    E.5.2.1Timepoint(s) of evaluation of this end point
    For all secondary time points baseline values will be compared to values at week 24.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard care
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    LVLS
    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 months0
    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 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 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: 32
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    women of child-bearing potential using contraception are allowed to participate in this trial
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 34
    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)
    none
    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 Decision2013-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
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