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    Summary
    EudraCT Number:2012-002773-64
    Sponsor's Protocol Code Number:RP103-07
    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:2013-11-01
    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 number2012-002773-64
    A.3Full title of the trial
    A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing the effectiveness of cysteamine bitartrate delayed-release capsules (RP103) in Patients with Cystinosis (Adult and Children 12 years and older)
    A.3.2Name or abbreviated title of the trial where available
    Superiority, Safety and Efficacy Study of RP103 in Cystinosis
    A.4.1Sponsor's protocol code numberRP103-07
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01733316
    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 SponsorHorizon Pharma USA, 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 supportHorizon Pharma Ireland Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHorizon Pharma USA, Inc.
    B.5.2Functional name of contact pointSenior Director, Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address150 South Saunders Road
    B.5.3.2Town/ cityForest Lake, IL
    B.5.3.3Post code60045
    B.5.3.4CountryUnited States
    B.5.4Telephone number+14154086284
    B.5.6E-mailskumar@horizonpharma.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 PROCYSBI
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Orphan B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/10/778
    D.3 Description of the IMP
    D.3.1Product nameCysteamine bitartrate (INN: mercaptamine bitartrate)
    D.3.2Product code RP103
    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.3.8INN - Proposed INNmercaptamine bitartrate
    D.3.9.1CAS number 27761-19-09
    D.3.9.2Current sponsor codeRP103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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 Yes
    D.2.1.1.1Trade name PROCYSBI
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Orphan B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/10/778
    D.3 Description of the IMP
    D.3.1Product nameCysteamine bitartrate (INN: mercaptamine bitartrate)
    D.3.2Product code RP103
    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.3.8INN - Proposed INNmercaptamine bitartrate
    D.3.9.1CAS number 27761-19-09
    D.3.9.2Current sponsor codeRP103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 3
    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 Cystagon 50mg
    D.2.1.1.2Name of the Marketing Authorisation holderOrphan Europe SARL
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCystagon
    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.3.8INN - Proposed INNmercaptamine bitartrate
    D.3.9.1CAS number 27761-19-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 4
    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 Cystagon 150mg
    D.2.1.1.2Name of the Marketing Authorisation holderOrphan Europe SARL
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCystagon
    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.3.8INN - Proposed INNmercaptamine bitartrate
    D.3.9.1CAS number 27761-19-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Cystinosis
    E.1.1.1Medical condition in easily understood language
    Cystinosis
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011777
    E.1.2Term Cystinosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of RP103 versus Cystagon® in controlling white blood cell cystine (WBC) levels over 24 hours in patients with cystinosis and to assess long-term safety and tolerability of RP103
    E.2.2Secondary objectives of the trial
    To compare WBC cystine measurements provided by a central
    laboratory versus sites’ local (regional, not associated with the
    clinical trial) laboratories.
    To assess long-term quality of life and sleep using instruments
    appropriate to the subjects’ age and region (US or Europe).
    To assess subject dosing compliance with two different
    cysteamine bitartrate formulations, Q6H immediate-release
    Cystagon® versus Q12H delayed-release RP103.
    To assess halitosis during Cystagon® and RP103 treatment in a
    subgroup of subjects
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Some cystinosis patients have bad breath (halitosis) when they take
    Cystagon. "Halitosis Substudy" is an optional portion of the study
    protocol, that will investigate the concentration of dimethylsulfide (DMS)
    in expired air – breath samples – after the administration of study
    medication and measuring PK samples at two visits: Substudy Visit 1
    while taking Cystagon and Substudy Visit 2 while taking RP103. The
    substudy visits occur at the same time as regularly scheduled study
    visits.
    E.3Principal inclusion criteria
    1. Male or female with a documented diagnosis of cystinosis.
    2. On a stable dose of Cystagon® for at least 21 days prior to Screening.
    3. WBC cystine level > 1 nmol ½ cystine/mg of protein on average over
    at least 2 measurements collected during the 2 years prior to Screening.
    4. No clinically significant change in liver function tests, i.e. 1.5 times
    ULN for ALT and AST, and/or 1.5 times ULN for total bilirubin, within 6
    months prior to Screening.
    5. No clinically significant change in renal function, i.e. estimated GFR
    within 6 months prior to Screening.
    6. Must have an estimated GFR > 20 mL/minute/1.73 m2 (using the
    equation from Schwartz 2009 J Am Soc Nephrol 20:629-637) 1.
    7. Female subjects who are sexually active and of childbearing potential,
    i.e. not surgically sterile (tubal ligation, bilateral oopherectomy, or
    hysterectomy) or at least 2 years naturally postmenopausal must agree
    to use an acceptable form of contraception from Screening through
    completion of the study. Acceptable forms of contraception for this study
    include hormonal contraceptives (oral, implant, transdermal patch, or
    injection) at a stable dose for at least 3 months prior to Screening,
    barrier (spermicidal condom or diaphragm with spermicide), IUD, or a
    partner who has been vasectomized for at least 6 months.
    8. Subject or their parent or guardian must provide written informed
    consent and assent (where applicable) prior to participation in the study.
    E.4Principal exclusion criteria
    1. Younger than 12 years of age.
    2. Current history of the following conditions or any other
    health issues that make it, in the opinion of the Investigator,
    unsafe for study participation:
    - Inflammatory bowel disease if currently active, or
    prior resection of small intestine;
    - Heart disease (e.g. myocardial infarction, heart
    failure, unstable arrhythmias, or poorly controlled
    hypertension) within 90 days prior to Screening;
    -Active bleeding disorder within 90 days prior to
    Screening;
    - History of malignant disease within 2 years prior to
    Screening.
    3. Hemoglobin level of < 9 g/dL at Screening or, in the opinion
    of the Investigator, a hemoglobin level that would make it
    unsafe for study participation.
    4. Known hypersensitivity to cysteamine and penicillamine.
    5. Female subjects who are nursing, planning a pregnancy, or
    are known or suspected to be pregnant.
    6. Subjects who, in the opinion of the Investigator, are not able or willing to comply with study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of steady-state cysteamine-trough WBC cystine
    levels between Cystagon® and RP103 over 3 months for each
    treatment period.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Months 1,2 and 3 vs Months 5,6 and 7
    (Comparing the Cystagon and RP103 3-month treatment periods)
    E.5.2Secondary end point(s)
    Safety Endpoints:
    The safety profile of RP103 will be investigated by changes
    from the last study visit as noted in the following safety
    assessments: physical examination, vital signs, ECG and
    clinical laboratory testing. Incidence of adverse event report
    (including attribution of treatment-emergent non-serious and
    serious adverse events) will be recorded.
    Pharmacokinetic Endpoint:
    Halitosis Substudy participants only: Cmax, Tmax and AUCs
    for plasma cysteamine and expired air DMS concentrations
    will be determined.
    Pharmacodynamic Endpoint:
    The WBC cystine content will be measured from samples
    collected within 15 minutes pre-dose under Cystagon® or 30
    minutes post-dose under RP103 at each study visit.
    Exploratory Endpoints:
    Central laboratory versus local laboratory WBC cystine
    values.
    The longitudinal change in the use of concomitant gastric
    acid reduction therapies, quality of life questionnaires, and VAS swallowing difficulty and sleep rating scale scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and secondary endpoints will be assesed following every pertinent study visit. Unless they discontinue the study, subjects will complete Screening, Day 1, an 8 bi-Monthly (every 2 week) visits, i.e. through Month 7 plus Termination Visit. If study drug is not yet approved , that will be followed by Quarterly visits, up to 24 Months.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 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 EEA12
    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
    Belgium
    France
    Germany
    Italy
    Netherlands
    United Kingdom
    United States
    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 visit of last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 Yes
    F.1.1Number of subjects for this age range: 15
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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 Decision2013-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-15
    P. End of Trial
    P.End of Trial StatusCompleted
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