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    Summary
    EudraCT Number:2021-006220-40
    Sponsor's Protocol Code Number:2022-0101-01
    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:2022-01-11
    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 number2021-006220-40
    A.3Full title of the trial
    Double-blinded randomized placebo-controlled trial on tacrolimus in women with an euploid pregnancy loss and PCOS and/or thyroid autoimmunity
    Behandling med tacrolimus af kvinder med et euploidt graviditetstab samt polycystisk ovariesyndrom og/eller thyroidea autoimmunitet - et randomiseret placebo kontrolleret studium
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tacrolimus treatment in women with pregnancy loss
    Tacrolimus og graviditetstab
    A.3.2Name or abbreviated title of the trial where available
    Tacrolimus treatment in women with pregnancy loss
    Tacrolimus og graviditetstab
    A.4.1Sponsor's protocol code number2022-0101-01
    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 SponsorHvidovre Hospital, Department of Gynecology
    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 supportNovo Nordic Foundation applied for funding
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet, Department of Medical Endocrinology and Metabolism
    B.5.2Functional name of contact pointSofie Bliddal
    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.5.6E-mailabli0007@regionh.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 Yes
    D.2.1.1.1Trade name Dailiport
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Capsule
    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 INNTacrolimus
    D.3.9.1CAS number 104987-11-3
    D.3.9.4EV Substance CodeSUB10797MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Polycystic ovarian syndrome and/or thyroid autoimmunity in combination with an euploid pregnancy loss
    Polycystisk ovaiesyndrom og/eller thyroideaautoimmunitet i kombination med et graviditetstab af et euploidt foster
    E.1.1.1Medical condition in easily understood language
    Polycystic ovarian syndrome and/or antibodies against the thyroid gland in combination with a pregnancy loss of a featus where the chromosome analysis was normal
    Polycystisk ovaiesyndrom og/eller antistoffer mod skjoldbruskkirtlen i kombination med et graviditetstab af et foster med normalt antal kromosomer
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065161
    E.1.2Term Polycystic ovarian syndrome
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10069094
    E.1.2Term Thyroid peroxidase antibody positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10060326
    E.1.2Term Thyroglobulin antibody positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10072314
    E.1.2Term Pregnancy loss
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test if immune modulation with low-dose tacrolimus can increase live birth rate in women with euploid PL and a diagnosis of PCOS and/or thyroid autoimmunity.
    Målet er at teste, om behandling med en lav dosis af tacrolimus gennem hele graviditeten øger chancen for et levendefødt barn blandt kvinder med PCOS og/eller thyroidea autoimmunitet og et tidligere graviditetstab af et euploidt foster.
    E.2.2Secondary objectives of the trial
    Not applicable
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Females diagnosed with Polycystic ovarian syndrome and/or thyroid autoimmunity in combination with an euploid pregnancy loss. Furthermore, the woman should actively want to achieve pregnancy again.
    Kvinder diagnosticeret med polycystisk ovaiesyndrom og/eller thyroideaautoimmunitet i kombination med et graviditetstab af et euploidt foster. Derudover skal kvinden ønske at opnå graviditet inden for den nærmeste fremtid.
    E.4Principal exclusion criteria
    Age under 18 years old, Severe uterine malformation. Known balanced maternal or paternal chromosomal abnormality, diagnosed with HIV, Hepatitis B or C, Currently treatment with immunmodulating medicine, kidney failure, previously treated with tacrolimus during pregnancy, previously participated in the study
    Alder < 18 år, betydende uterine anomalier, balancerede kromosomanomalier hos en af forældrene, diagnosticeret med HIV, hepatitis B eller C , fast behandling med immunmodulerende medicin såsom systemisk binyrebarkhormon, svær nyreinsufficiens , tidligere behandlet med tacrolimus i forbindelse med graviditet, tidligere deltagelse i forsøget
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is an increase in live birth of 15% resulting in a live birth rate of 76% in the tacrolimus group
    Primære endpoint er at øge chancerne for et levendefødt barn med 15% hos gruppen der behandles med tacrolimus.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will be evaluated after the last included female has given birth, or had a pregnancy loss
    Det primære end point vil blive evalueret efter den sidste inkluderede kvinde har født, eller har haft et graviditetstab.
    E.5.2Secondary end point(s)
    Secondary end points are: Ongoing pregnancy at the 4 follow-up visits during pregnancy. Ploidi status of a pregnancy loss during the clinical trial, the incidence of extrauterine pregnancies, chromosome analysis in fetuses where pregnancy is terminated,
    Finally, obstetric and perinatal complications in the two allocation groups are compared by monitoring birth weight, gestational age at birth (or at pregnancy loss), delivery method, Apgar score after 1 and after 5 minutes, and admission to and duration at neonatal intensive care unit.
    Post-partum thyroiditis rate, Thyroid peroxidase antibody (TPOAbs) and Thyroglobulin antibody (TgAbs) concentration, thyroid status, PCOS related biochemical status, Thyroid-Related Patient-Reported Outcome score (THYPRO), Perceived Stress Scale score (PSS) and Major Depression Inventory score (MDI).
    De sekundære end points er raten af ongoing graviditeter ved de 4 follow-up besøg. Ploidistatus af graviditetstab som sker under forsøget registreres. Forekomsten af ekstrauterine graviditeter. Kromosomanalyse hos fostre, hvor graviditeten afbrydes.
    Endelig sammenlignes obstetriske og perinatale komplikationer i de to allokeringsgrupper ved monitorering af fødselsvægt, gestationsalder ved fødsel (eller ved fostertab), fødselsforløb, Apgar score efter 1. og efter 5 minutter, samt indlæggelse og indlæggelsesvarighed.
    Post-partum thyroiditis rate, TPOAbs og TgAbs koncentrationen, thyroidea status, PCOS relateret biokemisk status, Thyroid-Related Patient-Reported Outcome score (THYPRO), Perceived Stress Scale score (PSS) og Major Depression Inventory score (MDI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary end points will be evaluated after the last included female has been to the last follow up visit 12 weeks after giving birth or after a pregnancy loss
    De sekundære endpoints vil blive evalueret efter den sidste inkluderede kvinde har været til sidste follow-up besøg 12 uger efter fødslen, eller efter et graviditetstab
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 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 concerned2
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 314
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 state314
    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
    Ingen
    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 Decision2022-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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