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    Summary
    EudraCT Number:2019-001572-11
    Sponsor's Protocol Code Number:LLB-2019-01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-07-01
    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
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-001572-11
    A.3Full title of the trial
    Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LHERP® in patients with recurrent genital herpes infections.
    Étude randomisée, contrôlée contre placebo, en double aveugle pour évaluer l’efficacité du 2LHERP® chez des patients présentant de l'herpès genital récurrent.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LHERP® in patients with recurrent genital herpes infections.
    Étude randomisée, contrôlée contre placebo, en double aveugle pour évaluer l’efficacité du 2LHERP® chez des patients présentant de l'herpès genital récurrent.
    A.3.2Name or abbreviated title of the trial where available
    HEARTH-GEN Study
    Etude HEARTH-GEN
    A.4.1Sponsor's protocol code numberLLB-2019-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04235322
    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 SponsorLABO’LIFE Belgium sprl
    B.1.3.4CountryBelgium
    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 supportLABO’LIFE Belgium sprl
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLabo’Life France
    B.5.2Functional name of contact pointClin Research Coord, Astrid Garreau
    B.5.3 Address:
    B.5.3.1Street Address1, rue François Bruneau
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44000
    B.5.3.4CountryFrance
    B.5.4Telephone number33659 11 39 29
    B.5.5Fax number33549 72 11 20
    B.5.6E-mailastrid.garreau@labolife.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 2LHERP®
    D.2.1.1.2Name of the Marketing Authorisation holderLABO’LIFE Belgium sprl
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 name2LHERP®
    D.3.4Pharmaceutical form Pillules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPillules
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients presenting recurrent genital herpes infections (4 or more episodes within the 12-months’ period prior to their study entry).
    E.1.1.1Medical condition in easily understood language
    Patients presenting recurrent genital herpes infections (4 or more episodes within the 12-months’ period prior to their study entry).
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10019972
    E.1.2Term Herpes viral infections
    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 PT
    E.1.2Classification code 10019948
    E.1.2Term Herpes simplex
    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 10018150
    E.1.2Term Genital herpes
    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
    Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes episodes at 12 months compared to placebo.
    E.2.2Secondary objectives of the trial
    Secondary objectives: comparison of the efficacy of 2LHERP® vs placebo, according to the following aspects:
    - number of episodes at 6 months,
    - remaining herpes infection recurrence free 6 and 12 months after the treatment initiation,
    - time to first episode during the treatment,
    - duration of episodes,
    - symptomatology during the entire relapse time,
    - use of Rescue Medication (RM),
    - evaluation of impact on the quality of life,
    - safety issues.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Man or woman over 18 years,
    - Patient presenting 4 or more episodes of genital herpes infections during the preceding 12-months’ period (prior to the study entry),
    - Woman of childbearing age under effective contraception,
    - Patient reporting a current stable sexual relationship (steady sexual partner during study duration),
    - Patient having faculties to understand and respect the constraints of the study,
    - Signature of the Informed Consent Form.
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding woman,
    - Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months,
    - Patient who had a suppressive antiviral therapy during last month,
    - Patient who wishes to continue his/her suppressive antiviral therapy,
    - Patient with known lactose intolerance,
    - Patient who participated in a clinical study in the previous 3-month period,
    - Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study,
    - Patient with severe immunodeficiency disease requiring long term treatment (*) or under chemotherapy or radiotherapy or corticoid therapy,
    - Patient under listed homeopathic or phytotherapy treatment,
    - Patient using or addicted to recreational drugs.
    (*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline within the number of episodes of genital herpes infection observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    - Number of episodes of herpes infections observed at month 6,
    - Patient remaining herpes infection recurrence free 6 months and 12 months after the treatment initiation,
    - Time to first recurrence of herpes infection during the treatment,
    - Mean duration of episodes, the duration for a given episode being defined as the number of days between the start of the episode and the last day before all symptoms recorded as ‘none’ for 2 consecutive days, in the patient diary,
    - Level of pain recorded daily on a visual analogue scale (100mm), as well as other associated symptomatology for genital (genital lesions/craks, difficulties to urinate, genital pruritus/burn, fever, QoL), which will be consequently measured as area under the curve (AUC),
    - Use of daily rescue medicine (RM), expressed with the cumulative number of days for the treatment period, the follow-up period and the entire study period.
    - 6-items questionnaire of quality of life,
    - Adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months,
    6 and 12 months ,
    until 6 months ,
    until 12 months,
    until 12 months,
    until 12 months,
    6 months and 12 months,
    until 6 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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state100
    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)
    There is no plan for treatment of the subject after the subject has ended participation in the trial. Each investigator will discuss of another treatment with the subject in case of unsuccessful trial treatment.
    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 Decision2020-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-04-18
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