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    Summary
    EudraCT Number:2013-004150-16
    Sponsor's Protocol Code Number:CL-503015
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-07-07
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-004150-16
    A.3Full title of the trial
    International Open-Label Extension of the Phase 3 Study CL-503012 with KIACTA™ in Patients with AA Amyloidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension of the CL-503012 study, which involved an investigation into the safety and efficacy of Kiacta™ in preventing kidney function decline in patients with AA amyloidosis, a disease associated with long-standing inflammatory disease, which can lead to the buildup of protein (amyloid A) inside the kidney and can cause kidney failure
    A.4.1Sponsor's protocol code numberCL-503015
    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 SponsorA.T. Development Switzerland SARL
    B.1.3.4CountrySwitzerland
    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 supportA.T. Development Switzerland SARL
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointAlexandre Hau
    B.5.3 Address:
    B.5.3.1Street Address27-35, rue Victor Hugo
    B.5.3.2Town/ cityIvry-sur-Seine Cedex
    B.5.3.3Post code94853
    B.5.3.4CountryFrance
    B.5.4Telephone number33983275178
    B.5.5Fax number33158465813
    B.5.6E-mailAlexandre.Hau@ppdi.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 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/3/01/051
    D.3 Description of the IMP
    D.3.1Product nameKIACTA
    D.3.2Product code NC-503
    D.3.4Pharmaceutical form Capsule
    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.3.8INN - Proposed INNEprodisate disodium
    D.3.9.1CAS number 36589-58-9
    D.3.9.2Current sponsor codeKIACTA
    D.3.9.3Other descriptive nameNC-503
    D.3.9.4EV Substance CodeSUB32021
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    AA Amyloidosis
    E.1.1.1Medical condition in easily understood language
    A disease associated with long-standing inflammatory disease, which can lead to the buildup of protein (amyloid A) inside the kidney and can cause kidney failure.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10002022
    E.1.2Term Amyloidosis
    E.1.2System Organ Class 10021428 - Immune system 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 primary objective of this open-label extension (OLE) study is to provide access to Kiacta
    (eprodisate disodium) for those patients who have completed the pivotal, randomized,
    placebo-controlled Phase 3 Study CL-503012.
    E.2.2Secondary objectives of the trial
    The secondary objective is to collect data on Kiacta safety and effectiveness in real-life
    situations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient has completed Study CL-503012, and has undergone all study assessments that
    could affect the primary endpoint of Study CL-503012
    - Patient is at least 18 years of age
    - Patient has a negative pregnancy test, if a female patient of childbearing potential
    - Patient is willing to use effective birth control method. Women of childbearing potential
    should continue to use effective birth control method as follows:
    - Oral contraception with an additional barrier method (since the investigational
    product may impair effectiveness of oral contraception)
    - Double-barrier method (diaphragm with spermicidal gel or condom with
    contraceptive foam)
    - Transdermal or long-acting injected contraceptive (e.g., depot
    medroxyprogesterone acetate [Depo-Provera®])
    - Intrauterine device or implantable contraceptive
    - Partner who is surgically sterile (vasectomy)
    - Total abstinence
    Nonsurgically sterile men should use double-barrier method as described above during
    intercourse for the duration of the treatment with Kiacta.
    - Patient has provided written informed consent to participate in this OLE study
    E.4Principal exclusion criteria
    - Patient has a CrCl ≤15 mL/min (as estimated by the Cockcroft-Gault formula prior to
    entering into the program
    - Patient has liver enzyme values (aspartate aminotransferase, alanine aminotransferase, or
    alkaline phosphatase) >5 times the upper limit of normal and/or total bilirubin >50%
    higher than the upper limit of normal
    - Patient progressed to ESRD during Study CL-503012. In Study CL-503012 ESRD was
    defined as one of the following:
    i. Presence of Stage 5 chronic kidney disease, i.e., established kidney failure
    with an eGFR <15 mL/min, obtained from 2 distinct SCr measurements
    separated by 2 to 4 weeks (Visit X and Visit X plus 2 to 4 weeks) or
    ii. Initiation of permanent renal replacement therapy, defined as a need for
    chronic dialysis (duration of 3 months or more) or transplantation
    - Patient was noncompliant while in Study CL-503012
    - Patient prematurely withdrawn from Study CL-503012
    - Patient has a clinically significant disease that could compromise patient’s safety
    - Patient suffers from active alcohol and/or drug abuse
    - Patient is pregnant or lactating, or patient is a woman of childbearing potential and is
    unwilling to use a clinically approved form of contraception during the program
    (continuous use of oral or long-acting injected contraceptive and/or use of an intra-uterine
    device or implantable contraceptive, and/or use of a barrier method of birth control)
    - Patient was on other investigational drug(s) given within 30 days prior to entry into this
    program or during this program (with the exception of study drug taken in previous
    CL-50312 program
    E.5 End points
    E.5.1Primary end point(s)
    Collection of data on Kiacta safety and effectiveness in real-life situations
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Egypt
    Lithuania
    Peru
    Poland
    Russian Federation
    Tunisia
    Ukraine
    United Kingdom
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 24
    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)
    After participation in the trial, if applicable, patients will be treated with the current standard therapy.
    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 Decision2014-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-06-20
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