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    Summary
    EudraCT Number:2019-004458-27
    Sponsor's Protocol Code Number:Krypto-3
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-13
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-004458-27
    A.3Full title of the trial
    Optimizing the fertility potential of bilateral cryptorchidism by treatment
    with adjuvant kryptocur.
    Optimering af fertilitetspotentialet ved bilateral kryptorkisme med
    supplerende kryptocur behandling.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimizing the fertility potential for boys with doublesided undescended
    testes by supplementary hormonal treatment.
    Optimering af fertilitetspotentialet for drenge med dobbelt sidige ikke
    nedstegne testikler med supplerende hormonbehandling.
    A.3.2Name or abbreviated title of the trial where available
    adjuvant kryptokur treatment
    adjuverende kryptokur behandling
    A.4.1Sponsor's protocol code numberKrypto-3
    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 SponsorRigshospitalet
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointRigshospitalet
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ citycopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535458541
    B.5.5Fax number4535453888
    B.5.6E-mailj-thorup@rh.dk
    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.2.1.1.1Trade name Kryptocur
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameKryptocur
    D.3.2Product code drug ID: 27415193612
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGONADORELIN
    D.3.9.1CAS number 33515-09-2
    D.3.9.2Current sponsor codegonadotropine-releasing hormone
    D.3.9.3Other descriptive namegonadorelin-releasing hormone (en)
    D.3.9.4EV Substance CodeSUB07960MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray, solution
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cryptorchidism
    Kryptorkisme
    E.1.1.1Medical condition in easily understood language
    Testicles that are not placed in the scrotum
    Testikler som ikke er på plads i pungen
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10056600
    E.1.2Term Cryptorchidism
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The project aims to improve the fertility potential for patients operated
    in early infancy for bilateral cryptorchidism but still having a high risk of
    infertility due to an underlying endocrinopathy. Furthermore, the aim of
    the study is to show that this selected group of bilateral cryptorchid boys
    with high risk of infertility, despite early surgery for undescended testes,
    will benefit from adjuvant postoperative hormone therapy and in case of
    treatment failure to rescue germ cells by cryopreservation, while germ
    cells are still present in the undescended testes.
    Projektet sigter mod at forbedre fertilitetspotentialet hos patienter, der
    opereres i den tidlige spædbarn for bilateral kryptorchidisme, men som
    stadig har en høj risiko for infertilitet på grund af en underliggende
    endokrinopati. Endvidere er formålet med undersøgelsen at vise, at
    denne udvalgte gruppe af bilaterale cryptorchid-drenge med stor risiko
    for infertilitet, på trods af tidlig kirurgi for ubesværede testikler, vil
    drage fordel af adjuvans postoperativ hormonbehandling og i tilfælde af
    behandlingssvigt med at redde kimceller ved kryopræservering , mens
    kimceller stadig er til stede i de uanfægtede testikler.
    E.2.2Secondary objectives of the trial
    Not applicable
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Bilateral cryptorchidism in 52 boys from 6 to 36 months of age at time of surgery. The germ cell number per tubular transverse section in testicular biopsies should be mean 0.2 to 0.5 and PLAP (placental alkaline phosphatase) positive germ cells should be present. The estimation of germ cell count is performed according to a method from our laboratory previously published . Serum levels of FSH and LH must not be increased above normal range .
    Bilateral kryptorchidisme hos 52 drenge fra 6 til 36 måneders alder på
    operationstidspunktet. Kimcelleantallet pr. Rørformet tværsnit i
    testikulære biopsier skal være middel 0,2 til 0,5, og PLAP (placental
    alkalisk phosphatase) positive kimceller skal være til stede. Skøn over
    antallet af kimceller udføres efter en metode fra vores tidligere
    publicerede laboratorium . Serumniveauer af FSH og LH må ikke øges
    over det normale område .
    E.4Principal exclusion criteria
    Another significant abnormality or earlier inguinal operation.
    Anden betydelig abnormalitet eller tidligere operation i lysken
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation: The effect of gonadotropin therapy is estimated by
    evaluation of the testis histopathology, estimation of the number of
    germ cells per tubular transverse section, presence of adult dark
    spermatogonia and hormone profile by 9 - 12 months of follow-up.
    Success criteria include the normalization of the germ cell number with
    significant increase in the kryptocur® group compared to the placebo
    group, presence of adult dark spermatogonia and normal serum inhibin-
    B.
    9 - 12 måneder efter primær-operationen tilbydes både
    hormonbehandlede og placebogruppen, ny hormonprofil, ny vævsprøve
    og nedfrysning af testikelvæv med henblik på eventuel senere
    fertilitetsbehandling (behandling af forplantningsevnen hvis
    hormonbehandlingen har været utilstrækkelig). Der foretages blindet
    evaluering af kønscelle status og hormonstatus. Herefter brydes koden
    og patienter der har fået placebo tilbydes aktiv behandling.
    Evaluering: Resultatet af hormon-behandlingen bedømmes ud fra
    evaluering af vævsundersøgelsen af testiklerne (stenene) og
    hormonprofilen ved 9-12 måneders efterundersøgelse. Success kriterier
    indbefatter normalisering af vævsprøverne og hormonprofilen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    When all data are available after last subject has completed the study, it
    will befinalized. Expected end of 2024
    Når alle data er tilgængelige efter sidste subject har afsluttet
    undersøgelsen, vil de blive finaliseret. Forventet slutning af 2024
    E.5.2Secondary end point(s)
    Not applicable
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Not applicable
    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 No
    E.6.5Efficacy No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 52
    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: 35
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 17
    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 No
    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
    patients are maximum 36 month old - informed consent given by parents
    patienterne er maximalt 36 måneder gamle - informeret samtykke gives af forældre
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state52
    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)
    placebo group will be offered active treament after break of coding. All will have cryopreservation of testicular tissue
    offered.
    placebogruppen tilbydes aktiv behandling efter koden er brudt.Alle tilbydes kryopreservering af testikelvæv.
    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 Decision2020-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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