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    Summary
    EudraCT Number:2011-005852-33
    Sponsor's Protocol Code Number:CCOA566B2306
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-04-11
    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 number2011-005852-33
    A.3Full title of the trial
    An open-label, single-arm study to evaluate the efficacy, safety and PK of artemether-lumefantrine Dispersible Tablet in the treatment of acute uncomplicated Plasmodium falciparum malaria in infants <5 kg Body Weight
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, safety and pharmacokinetics of artemether-lumefantrine dispersible tablet in the treatment of malaria in infants < 5 kg
    A.4.1Sponsor's protocol code numberCCOA566B2306
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/177/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma AG
    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 supportMedicines for Malaria Venture (MMV)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovarits Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.6E-mailclinicaltrial.enquiries@novartis.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameartemether-lumefantrine
    D.3.2Product code COA566
    D.3.4Pharmaceutical form Dispersible tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNARTEMETHER
    D.3.9.1CAS number 71963-77-4
    D.3.9.2Current sponsor codeCOA566
    D.3.9.4EV Substance CodeSUB05574MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLUMEFANTRINE
    D.3.9.1CAS number 82186-77-4
    D.3.9.2Current sponsor codeCOA566
    D.3.9.4EV Substance CodeSUB08618MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
    E.1.1.1Medical condition in easily understood language
    Malaria, Falciparum
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10025487
    E.1.2Term Malaria
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a 3-day regimen of artemether-lumefantrine dispersible in infants <5 kg of BW with acute uncomplicated P. falciparum malaria using the polymerase chain reaction (PCR)-corrected 28-day parasitological cure rate.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of a 3-day regimen of artemether-lumefantrine dispersible tablet in infants <5 kg of BW with acute uncomplicated P. falciparum malaria by other parameters as specified in section E.5.2.

    To evaluate the safety of a 3-day regimen of artemether-lumefantrine dispersible tablet in infants <5 kg of BW with acute uncomplicated P. falciparum malaria, with respect to the incidence of serious adverse events (SAEs), adverse events (AEs) and routine safety laboratory assessments.

    To investigate the PK of artemether-lumefantrine during and following treatment with a 3-day regimen of artemether-lumefantrine dispersible tablet in infants <5 kg of BW with acute uncomplicated P. falciparum malaria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Neonates / infants
    •Body weight < 5 kg
    •In cohort 1, infants aged > 28 days; in cohort 2, neonates of a term age 0 to ≤ 28 days
    •Microscopically confirmed diagnosis of acute uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmodium falciparum parasitaemia of > 1,000 and < 100,000 parasites/µL
    E.4Principal exclusion criteria
    •Presence of severe malaria (according to World Health Organization definition)
    •Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants)
    •Presence of any clinically significant neurological condition
    •Presence of clinically significant abnormality of the hepatic and renal systems
    •Patients who sustained a significant blood volume loss (> 3% of calculated blood volume) in the past 30 days
    •Patients unable to swallow or whose drinking is impaired
    •Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease
    •Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
    •Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities
    •Other protocol-defined inclusion/exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the PCR-corrected 28-day parasitological cure rate, defined as the proportion of patients with clearance of asexual parasites within 7 days of initiating study treatment without recrudescence at Day 28, corrected for re-infection by PCR assay.
    Parasitaemia results will be taken from the central microscopy reading.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    Secondary efficacy variables are:
    • PCR-corrected parasitological cure rate at Day 14 and Day 42 (based on central microscopy reading)
    • Parasitological uncorrected cure rate at Day 3, Day 7, Day 14, Day 28, and Day 42 (based on central microscopy reading)
    • Percent parasite reduction at 24 hours after treatment initiation (based on central microscopy reading)
    • Number of patients with parasitaemia at 72 hours after treatment initiation greater than or equal to 25 percent of count at baseline (based on central microscopy reading)
    • Number of patients with parasitaemia at 48 hours after treatment initiation greater than at baseline (based on central microscopy reading)
    • Time to parasite clearance (PCT), defined as time from first dose until first total and
    continued disappearance of asexual parasite forms which remains at least a further 48 hours (based on central microscopy reading)
    • Time to fever clearance (FCT), defined as time from first dose until the first time the axillary body temperature decreased below and remained below 37.5° C for at least a further 48 hours
    • Time to gametocyte clearance (GCT), defined as time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours (based
    on central microscopy reading)
    • Gametocyte carriage over time (based on central microscopy reading)

    Safety endpoints are
    • Incidence of serious adverse events
    • Incidence of adverse events
    • Routine safety laboratory assessments
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 7, 14, 28 and 42 days
    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 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
    Benin
    Burkina Faso
    Congo
    Nigeria
    Togo
    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.8.9.2In all countries concerned by the trial years1
    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: 30
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 15
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 15
    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, neonates
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Burkina Faso
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