Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2023-000804-21
    Sponsor's Protocol Code Number:CCOA566B2307
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2024-07-29
    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 number2023-000804-21
    A.3Full title of the trial
    Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether:Lumefantrine (2.5 mg:30 mg) Dispersible Tablet in the Treatment of Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria (CALINA)
    A.4.1Sponsor's protocol code numberCCOA566B2307
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04300309
    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 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 supportEuropean and Developing Countries Clinical Trials Partnership
    B.4.2CountrySouth Africa
    B.4.1Name of organisation providing supportMedicines for Malaria Venture
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportGroupe de Recherche Action en Santé
    B.4.2CountryBurkina Faso
    B.4.1Name of organisation providing supportInstitut de Recherche en sciences de la Santé - Unité de Recherche Clinique de Nanoro
    B.4.2CountryBurkina Faso
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Disclosure Office
    B.5.3 Address:
    B.5.3.1Street AddressNovartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41613241111
    B.5.6E-mailNovartis.email@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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB05574MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.3.9.4EV Substance CodeSUB08618MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Plasmodium Falciparum Malaria
    E.1.1.1Medical condition in easily understood language
    Uncomplicated malaria
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10035500
    E.1.2Term Plasmodium falciparum infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10016171
    E.1.2Term Falciparum 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 assess the key PK parameter of artemether in
    infants and neonates < 5 kg body weight dosed with
    the new formulation of artemether-lumefantrine
    dispersible tablet
    E.2.2Secondary objectives of the trial
    -To assess other key PK parameters of artemether,
    DHA and lumefantrine in infants and neonates <5
    kg body weight dosed with the new formulation of
    artemether-lumefantrine dispersible tablet
    -To evaluate the safety and tolerability of the new
    formulation of artemether-lumefantrine dispersible
    tablet in infants and neonates <5 kg body weight
    with acute uncomplicated P. falciparum malaria
    -To determine the efficacy of the new formulation of
    artemether-lumefantrine dispersible tablet for
    treatment of acute uncomplicated P. falciparum
    malaria in infants and neonates <5 kg body weight
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female neonates/infants
    2) Body weight <5 kg but ≥ 2 kg
    3) In Cohort 1, infants aged >28 days; in Cohort 2, neonates aged 1 to ≤28 days (3 subgroups: 1-7 days; 8-14 days; 15-28 days)
    4) Microscopically confirmed diagnosis of P. falciparum malaria (or mixed infections):
    in Cohort 1 of ≥500 and <100,000 parasites/µL asexual P. falciparum parasitemia
    in Cohort 2 of ≥100 and <100,000 parasites/µL asexual P. falciparum parasitemia
    in Cohort 2, either congenital or neonatal
    either symptomatic or asymptomatic
    E.4Principal exclusion criteria
    1) Head circumference < - 2 SD z-score in cm following WHO age and sex-specific reference curves (suspicion of microcephaly)
    2) Presence of severe malaria (according to WHO 2015 definition)
    3) HIV status :
    -in Cohort 1, patient's or patient's mother's current treatment with ARV
    -in Cohort 2, mother's known HIV positive status at patient's birth or mother's current treatment with ARV
    4) 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) (WHO 2005)
    5) Presence of any clinically significant neurological condition:
    -any episode of convulsion during the present illness (in keeping with the IMCI list of general danger signs)
    -known neurological disorders (e.g. chronic seizure disorders, cerebral palsy)
    6) Presence of clinically significant abnormality of the hepatic and renal systems
    7) Patients unable to swallow or whose drinking is impaired
    8) Known hypersensitivity of the patient or either patient's parent to artemether, lumefantrine, any of the excipients of Coartem®/Riamet® Dispersible tablet, or to drugs of similar chemical classes
    9) History of malabsorption or previous gastrointestinal surgery, or history of radiation therapy that could affect drug absorption or metabolism, or any other disorder or history of a condition that could interfere with drug absorption, distribution, metabolism, or excretion
    10) Known 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
    11) Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
    12) Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities
    13) Patients who received any antimalarial drug, including antibiotics with antimalarial activity, within 14 days of trial start, or any other prohibited drug (see Table 6-2)
    14) Patients who received an investigational drug within 5 half-lives of enrollment or participated in an investigational study or within 30 days, whichever is longer
    E.5 End points
    E.5.1Primary end point(s)
    ART Cmax (represents the higher concentration between the concentrations at 1 hour and 2 hours after first dose)
    E.5.1.1Timepoint(s) of evaluation of this end point
    ART Cmax (represents the higher concentration between the concentrations at 1 hour and 2 hours after first dose)
    E.5.2Secondary end point(s)
    1) Lumefantrine Day 8 concentration (C168h) - 168h post first dose
    2) Artemether AUC: Up to Day 15 post first dose
    3) DHA AUC: Up to Day 15 post first dose
    4) Lumefantrine Cmax: Up to Day 8 post first dose
    5) Lumefantrine AUC: Up to Day 15 post first dose
    6) Parasite Clearance Time (PCT): Up to Day 8
    7) Fever clearance Times (FCT): Up to Day 8
    8) PCR-corrected Adequate Clinical and Parasitological Response (ACPR): Day 15, 29, 43
    9) Uncorrected Adequate Clinical and Parasitological Response (ACPR): Day 8, 15, 29, 43
    10) Incidence rate of recrudescence and new infections: Up to Day 43
    11) Incidence rate of serious adverse events: during the study period from Baseline up to age 365 days
    12) Incidence rate of adverse events: during the study period from Baseline up to day 43
    13) Incidence rate of abnormal laboratory values: during the study period from Baseline up to day 43
    14) Change in head circumference: at Baseline and at age 365 days
    15) Neurodevelopmental assessment: At Day 4 and at age 365 days
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 168h post first dose
    2) Up to Day 15 post first dose
    3) Up to Day 15 post first dose
    4) Up to Day 8 post first dose
    5) Up to Day 15 post first dose
    6) Up to Day 8
    7) Up to Day 8
    8) Day 15, 29, 43
    9) Day 8, 15, 29, 43
    10) Up to Day 43
    11) during the study period from Baseline up to age 365 days
    12) during the study period from Baseline up to day 43
    13) during the study period from Baseline up to day 43
    14) at Baseline and at age 365 days
    15) at Day 4 and at age 365 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 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) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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, The Democratic Republic of the
    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
    10.05.2024
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days11
    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: 22
    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: 22
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 22
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 Information not present in EudraCT
    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 44
    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)
    N/A
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Congo, The Democratic Republic of the
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 06 23:14:40 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA