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    Summary
    EudraCT Number:2020-004200-33
    Sponsor's Protocol Code Number:CEGA230B2404
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-06-05
    Trial 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 number2020-004200-33
    A.3Full title of the trial
    A Phase IV, multi-center, open-label study to determine the
    safety, tolerability and clinical outcomes following oral
    administration of EGATEN™ (Triclabendazole) in patients
    (6 years of age or older) with fascioliasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of safety, tolerability and efficacy of Egaten in fascioliasis patients
    A.4.1Sponsor's protocol code numberCEGA230B2404
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04230148
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    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/ city Basel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 613241111
    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 Yes
    D.2.1.1.1Trade name Egaten
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma S.A.S.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameTriclabendazole
    D.3.2Product code EGA230
    D.3.4Pharmaceutical form Tablet
    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 INNTriclabendazole
    D.3.9.1CAS number 68786-66-3
    D.3.9.2Current sponsor codeEGA230
    D.3.9.4EV Substance CodeSUB11267MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Fascioliasis
    E.1.1.1Medical condition in easily understood language
    Liver fluke infection
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 28.0
    E.1.2Level PT
    E.1.2Classification code 10016234
    E.1.2Term Fascioliasis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety and tolerability of Egaten
    administered as two 10 mg/kg doses given
    approximately 12 hours apart in subjects with
    fascioliasis.
    E.2.2Secondary objectives of the trial
    To evaluate clinical response in acute and chronic Fascioliasis subjects on Day 10
    To evaluate clinical cure rate in Acute Fascioliasis subjects on, Day 30, Day 60 and Day 90.
    To evaluate parasitological cure rate of chronic fascioliasis subjects at Day 10, Day 30, Day 60 and Day 90.
    To evaluate clinical cure rate of chronic fascioliasis subjects at Day 30, Day 60 and Day 90.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any study protocol specific assessment is performed other than procedures performed as part of standard of care.

    2. Subjects (Adult and pediatric subjects ≥ 6 years of age and ≥ 18 kg of weight) with confirmed diagnosis of fascioliasis.
    E.4Principal exclusion criteria
    2. Subjects with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in Egaten.
    6. Females (including under the age of 18) known to be pregnant or testing positive for pregnancy at screening.
    7. Lactating women unwilling to discontinue lactation up to 72 hours after the second dose administration or as per local guidelines.
    10. Subjects with medical history of QT prolongation or a history of symptoms compatible with a long QT interval or on medication which prolong the QT interval.
    11. Patients with a resting QTcF ≥480 msec or inability to determine the QTcF interval at screening.
    E.5 End points
    E.5.1Primary end point(s)
    Safety/tolerability assessments (incidence of
    serious adverse events (SAEs), adverse events
    (AEs), and laboratory assessments)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout study
    E.5.2Secondary end point(s)
    At Day 10, improvement or resolution of baseline signs and symptoms
    At Day 30, Day 60 and Day 90, proportion of subjects with: • Resolution of baseline signs and symptoms. • Improvement in baseline lab parameters. • Improvement in baseline ultrasound findings.
    Proportion of subjects with absence of fasciola eggs confirmed by stool examination at Day 10, Day 30, Day 60 and Day 90.
    At Day 30, Day 60 and Day 90 proportion of subjects with : • Resolution of baseline signs and symptoms. • Improvement in baseline lab parameters. • Improvement in baseline ultrasound findings.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 10, 30, 60, 90
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Colombia
    Egypt
    Peru
    Türkiye
    Viet Nam
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years5
    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: 24
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 14
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors
    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)
    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: Egypt
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