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    Summary
    EudraCT Number:2022-000608-36
    Sponsor's Protocol Code Number:UKER-MFHO-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-03-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2022-000608-36
    A.3Full title of the trial
    Prospective, randomized, controlled, open, multicenter clinical trial on the efficacy and safety of materno-fetal hyperoxygenation (MFHO) during the third trimester of pregnancy to treat underdeveloped left ventricular structures of the fetus
    Prospektive, randomisierte, kontrollierte, offene, multizentrische klinische Prüfung der Wirksamkeit und Sicherheit materno-fetaler Hyperoxygenierung (MFHO) in der Spätschwangerschaft bei unterentwickelten Linksherzstrukturen des Fetus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Maternal oxygen therapy during pregnancy for unborn babies with underdeveloped structures on the left side of the heart
    Mütterliche Sauerstofftherapie während der Schwangerschaft zur Behandlung unterentwickelter Linksherzstrukturen beim noch ungeborenen Kind
    A.3.2Name or abbreviated title of the trial where available
    HYPEROX
    HYPEROX
    A.4.1Sponsor's protocol code numberUKER-MFHO-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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    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 supportHECTOR foundation
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen
    B.5.2Functional name of contact pointKinder- und Jugendklinik
    B.5.3 Address:
    B.5.3.1Street AddressLoschgestr. 15
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number004991318533775
    B.5.5Fax number004991318533013
    B.5.6E-mailholm.schneider@uk-erlangen.de
    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.2.1.2Country 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 nameO2, gas for medical purposes
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameoxygen, medical gas
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit l litre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Yes
    D.3.11.13.1Other medicinal product typemedical gas
    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
    underdeveloped left ventricular structures in human fetus
    hypoplastische Linksherzstrukturen beim menschlichen Fetus
    E.1.1.1Medical condition in easily understood language
    unborn baby with developmental disorder of the left side of the heart
    noch ungeborenes Kind mit Entwicklungsstörung des linken Herzens
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021076
    E.1.2Term Hypoplastic left heart syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evidence of efficacy of materno-fetal hyperoxygenation (MFHO) during the third trimester of pregnancy on growth of underdeveloped fetal left ventricular structures
    Nachweis der Wirksamkeit materno-fetaler Hyperoxygenierung (MFHO) in der Spätschwangerschaft auf das Wachstum unterentwickelter fetaler Linksherzstukturen
    E.2.2Secondary objectives of the trial
    Evaluation of
    - safety of MFHO during late pregnancy for mother/child
    - Impact of MFHO during late pregnancy on infant development post partum
    - Impact of MFHO during late pregnancy on fetal brain development
    - Impact of MFHO during late pregnancy on infant brain development
    - Impact of MFHO during late pregnancy on nature and frequency of cardiac surgery and catheter interventions in infants
    Untersuchung
    - der Sicherheit der MFHO in der Spätschwangerschaft für Mutter und Kind
    - des Einflusses der MFHO in der Spätschwangerschaft auf die nachgeburtliche Entwicklung des Kindes
    - des Einflusses der MFHO in der Spätschwangerschaft auf die Hirnentwicklung des Fetus
    - des Einflusses der MFHO in der Spätschwangerschaft auf die Hirnentwicklung des geborenen Kindes
    - des Einflusses der MFHO in der Spätschwangerschaft auf Art und Häufigkeit postnataler kardiochirurgischer Eingriffe und Katheter-Interventionen beim Kind
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    mother:
    - >= 18 years of age
    - third trimester of pregnancy
    - non-smoker
    - A. uterina doppler ultrasound at least one-sided without pathological findings
    Fetus:
    - cardiac disorder with at least one underdeveloped left ventricular structure detected by echocardiography
    - sufficient fetal cardiac function
    Mutter:
    - Alter>= 18 Jahre
    - Einzelschwangerschaft im 3. Trimenon
    - Nichtraucherin
    - A. uterina-Doppler mind. auf einer Seite nicht relevant pathologisch verändert
    Fetus:
    - Diagnose eines Herzfehlers mit echokardiographischem Nachweis mind. einer deutlich unterentwickelten Linksherzstruktur
    - ausreichende fetale Herzfunktion
    E.4Principal exclusion criteria
    Mother:
    - alcohol or drug abuse
    - multiple pregnancy
    - adipositas permagna (BMI>40)
    - diabetes melllitus, insulin-dependent
    - obstetrical issues (e.g. Cervix uteri <25mm, premature contractions, preeclampsia, eclampsia, HELLP Syndrome, …)
    - fetus impossible to evaluate by echocardiography
    - patholog. utero-placental resistance
    - cardiac failure (NYHA III/IV or decompensated)
    - severe COPD, hypercapnia
    Fetus:
    - underlying disease or chromosomal abnormality which might influence the effect of MFHO
    - hemodynamic factors with influence on filling/emptying of the left heart which might affect MFHO efficacy
    - fetal cardiac failure
    - Hydrops fetalis
    - severe growth retardation
    - no flow in A. umbilicalis
    - severe extracardiac malformations
    - visit 2: inadequate response to O2 provocation during echocardiography
    Mutter
    - Alkohol- oder Drogenabusus
    - Mehrlingsschwangerschaft
    - Adipositas permagna (BMI>40)
    - insulinpflichtiger Diabetes mellitus
    - Geburtshilfliche Probleme (z.B. Cervixlänge <25mm, vorzeitige Wehen, Präeklampsie, Eklampsie, HELLP-Syndrom,...)
    - echokardiographische Beurteilung des Fetus unmöglich
    - pathologischer utero-plazentarer Widerstand
    - Herzinsuffizienz (NYHA III/IV oder dekompensiert)
    - schwere COPD mit chron. Hyperkapnie
    Fetus:
    - Fetale Grunderkrankung oder chromosomale Abnormalität, die einen verminderten Effekt der MFHO erwarten lässt
    - Vorliegen hämodynamischer, die Füllung oder Entleerung der linken Herzseite beeinträchtigender Faktoren, die den gewünschten Therapieeffekt einschränken
    - fetale Herzinsuffizienz
    - Hydrops fetalis
    - Schwere Wachstumsretardierung
    - Null-Fluss in der A. umbilicalis
    - große extrakardiale Fehlbildungen
    - Visite 2: inadäquates Ansprechen auf die O2-Provokation in der qualifizierenden Echokardiografie
    E.5 End points
    E.5.1Primary end point(s)
    median change of the sum of the Z-scores of the initially chosen echocardiographic fetal heart structures under O2 provocation at the time point PW35d0 (+/- 2 days) compared to the initial values on PW32d0 (+/- 2 days) under O2 provocation.
    mittlere Änderung der Summe der Z-Scores der in der fetalen Echokardiographie initial gewählten Herzstruktur(en) eines Fetus unter 02-Provokation am Zeitpunkt SSW35 T0 (+/- 2 Tage) gegenüber den Ausgangswerten in SSW32 T0 (+/- 2 Tage) unter 02-Provokation
    E.5.1.1Timepoint(s) of evaluation of this end point
    PW35d0 (+/- 2 days) compared to PW32d0 (+/- 2 days)
    SSW35 T0 (+/- 2 Tage) gegenüber SSW32 T0 (+/- 2 Tage)
    E.5.2Secondary end point(s)
    - number of maternal AE and SAE
    - number of fetal /newborn AE and SAE
    - number of maternal AR and SAR
    - number of fetal /newborn AR and SAR
    - neurological development of the child
    - head growth intrauterine and postnatal
    - option of biventricular correction of the cardiac defect (y/n)
    - univentricular palliation necessary (y/n)
    - aortic coarctation requiring treatment (y/n)
    - nature and number of postnatal cardiosurgical interventions
    - nature and number of postnatal catheter interventions
    - occurence of retinopathy
    - occurence or periventricular leucomalacia
    - Auftreten von AEs und SAEs bei der Mutter im Beobachtungszeitraum (Baseline, V2, Tag 1 bis 72 Stunden nach Geburt [Ende V7])
    - Auftreten von AEs und SAEs beim Fetus bzw. beim geborenen Kind im Beobachtungszeitraum (Baseline, V2, Tag 1 bis 72 Stunden nach Geburt [Ende V7])
    - Auftreten von ARs und SARs bei der Mutter im Beobachtungszeitraum (Baseline, V2, Tag 1 bis V10 (EOS))
    - Auftreten von ARs und SARs beim Fetus bzw. beim geborenen Kind im Beobachtungszeitraum (Baseline, V2, Tag 1 bis V10 (EOS))
    - Neurologische Entwicklung des Kindes anhand neurologischer Entwicklungstests (Bayley Scales, Thompson Score)
    - Kopfwachstum des Kindes intrauterin und postnatal im Beobachtungszeitraum
    - Möglichkeit der biventrikulären Korrektur des Herzfehlers im Beobachtungszeitraum (ja / nein)
    - Univentrikuläre Palliation im Behandlungszeitraum? (ja / nein)
    - Behandlungsbedürftige Aortenisthmusstenose im Beobachtungszeitraum? (ja / nein)
    - Art und Anzahl postnataler kardiochirurgischer Interventionen beim Kind im Beobachtungszeitraum
    - Art und Anzahl postnataler kinderkardiologischer Katheter-Interventionen beim Kind im Beobachtungszeitraum
    - Auftreten einer Retinopathie beim Kind im Beobachtungszeitraum
    - Auftreten von periventrikulärer Leukomalazie beim Kind
    E.5.2.1Timepoint(s) of evaluation of this end point
    AE/SAE: from visit 2 until visit 7
    all others: from visit 2 until visit 10 (EOS)
    AE/SAE: Visite 2 bis Visite 7
    alle anderen: Visite 2 bis Visite 10 (EOS)
    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 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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    gleiches IMP, unterschiedlicher Verabreichungszeitpunkt (Arm A: Start O2 zu SSW 32 vs. Arm B: SSW35)
    same IMP, different time of administration (arm A: start O2 PW 32 vs. arm B: start O2 PW 35)
    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 concerned13
    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 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
    LVLS
    Letzte Visite des letzten Prüfungsteilnehmers (LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    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: 64
    F.1.1.1In Utero Yes
    F.1.1.1.1Number of subjects for this age range: 64
    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: 64
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Fetus/newborn/infant
    Fetus/Neugeborenes/Säugling
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state64
    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)
    Standard of care according to current treatment guidelines
    Leitliniengerechte Standardtherapie
    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 Decision2022-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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