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    Summary
    EudraCT Number:2013-002255-15
    Sponsor's Protocol Code Number:ST3073-ST3074-DM-12-002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-11-04
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2013-002255-15
    A.3Full title of the trial
    A phase II, open-label, multicentre, pharmacokinetic, pharmacodynamics and safety study of a new paediatric eurartesim dispersible formulation and crushed film coated eurartesim tablet, in infant patients
    with Plasmodium falciparum malaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study to compare a new paediatric eurartesim dispersible formulation and crushed film coated eurartesim tablet, in infant patients with Plasmodium falciparum malaria
    A.4.1Sponsor's protocol code numberST3073-ST3074-DM-12-002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/227/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    B.1.3.4CountryItaly
    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 supportsee section B.1
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    B.5.2Functional name of contact pointClinical Research Department
    B.5.3 Address:
    B.5.3.1Street AddressVia Pontina km 30.400
    B.5.3.2Town/ cityPomezia
    B.5.3.3Post code00040
    B.5.3.4CountryItaly
    B.5.4Telephone number00390691393916
    B.5.5Fax number00390691393757
    B.5.6E-mailgiovanni.valentini@sigma-tau.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 nameEurartesim
    D.3.4Pharmaceutical form Dispersible tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral 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
    Uncomplicated Plasmodium falciparum malaria
    E.1.1.1Medical condition in easily understood language
    Uncomplicated Plasmodium falciparum malaria
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the PK of the eurartesim (PQP/DHA) new water dispersible formulation, film coated tablet and crushed film coated tablet in venous blood samples during and after a therapeutic course of Eurartesim in paediatric population
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of eurartesim in treating uncomplicated malaria episodes and its ability in protecting patients from reinfections and/or recrudescence.
    •To assess the PK/PD relationship of eurartesim in malaria patients.
    •To evaluate safety and tolerability of eurartesim in infants.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and Female infants aged from 6 months to ≤ 12 months included.
    •Ability to swallow oral suspension.
    •Body weight 5 kg.
    •Uncomplicated malaria, with microscopically confirmed mono-infection by P. falciparum (parasitaemia ≥1000/L and <200000/L).
    •History of fever anytime during the preceding 48 hours or presence of fever (axillary temperature ≥37.5 °C or ≥38.0 °C rectally).
    •Ability of parents or guardians to understand the nature of the trial and providing signed informed consent.
    •Stable residence in the study area during the two months after recruitment and willingness to comply with the study protocol and the study visit schedule.
    E.4Principal exclusion criteria
    •Antimalarial treatment with amodiaquine, chloroquine, quinine or lumefantrine-based compounds within the previous 6 weeks, with piperaquine-based compound, or mefloquine, or sulphadoxine pyrimethamine (SP) within the previous 3 months and with halofantrine within the 30 days prior to screening.
    •Any other antimalarial treatment or antibiotics with antimalarial activity (including cotrimoxazol) and any herbal products, within the 7 days prior to screening.
    •Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference).
    •Severe vomiting or dehydration.
    E.5 End points
    E.5.1Primary end point(s)
    •To estimate the population and individual PK parameters and variability of PQ and DHA in the paediatric population when administered with eurartesim.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be collected over 72 h from eurartesim dosing during admission and then on Days 7, 14 and 21, according to the sparse blood sampling collections. The children, discharged from the clinical unit after the blood samples collection time at Day 3, will need to come back on Days 7, 14, 21, 28 and 42.
    E.5.2Secondary end point(s)
    •Day 28 polymerase chain reaction (PCR) corrected Adequate Clinical and Parasitological Response (ACPR).
    •Day 28 Crude (PCR uncorrected) ACPR.
    •Proportion of patients with early and late treatment failure.
    •Asexual parasite density and clearance time (PCT).
    •Fever clearance time (FCT).
    •Gametocyte carriage over time.
    •Cure rates at Day 42 (PCR corrected and PCR uncorrected).
    •Kaplan Maier survival analysis for all recurrences over time.
    •Kaplan Maier survival analysis for new infections over time.
    •Kaplan Maier survival analysis for recrudescence over time.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Malaria blood smear (thick and thin blood films) will be performed at the following days:
    oAt screening (Day 0) and repeated in the afternoon in case of morning study drug administration (before 12:00 am),
    oIn the morning and afternoon on Day 1, Day 2 (till to two consecutive negative results) and then at Day 3 before discharge, Day 7, Day 14 (±1), Day 21 (-1),Day 28 (±3) and Day 42 (3),
    oIn occasion of any PK blood drawing till Day 2 included (only thick blood film).

    PCR sampling at:
    oAt screening (Day 0) and subsequently from Day 7 at any scheduled or unscheduled visit within 42 days follow-up.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Burkina Faso
    Congo
    Gambia
    Mozambique
    Tanzania, United Republic of
    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.8.9.2In 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 Yes
    F.1.1Number of subjects for this age range: 300
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 300
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants aged from 6 to < 12 months
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 300
    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 with treatment failure will be treated and followed up as per local guidelines for malaria treatment till full recovery, but they will not continue to have study investigations performed after the discontinuation from the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CNRFP
    G.4.3.4Network Country Burkina Faso
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation MRC Unit
    G.4.3.4Network Country Gambia
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation NIMR
    G.4.3.4Network Country Tanzania, United Republic of
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation CISM
    G.4.3.4Network Country Mozambique
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation University Kinshasa
    G.4.3.4Network Country Congo
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Gambia
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