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    Summary
    EudraCT Number:2020-003570-49
    Sponsor's Protocol Code Number:KB065
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003570-49
    A.3Full title of the trial
    Phase III, Open-label, Uncontrolled, Multicenter Study to Assess Efficacy, Pharmacokinetics and Safety of IMMUNORHO in the Prevention of RhD Isoimmunization in Rh(D) negative Women Pregnant with Rh(D) positive Foetuses
    Studio di fase III, in aperto, non controllato, multicentrico per valutare l’efficacia, la farmacocinetica e la sicurezza di IMMUNORHO nel prevenire l’isoimmunizzazione RhD in donne con Rh(D) negativo gravide di un nascituro Rh(D) positivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the efficacy and safety of IMMUNORHO in the prevention of immune response of Rh(D) negative Women Pregnant with Rh(D) positive Foetuses
    Uno Studio per valutare l’efficacia, e la sicurezza di IMMUNORHO nel prevenire la risposta immunitaria di donne con Rh(D) negativo incinte di un nascituro Rh(D) positivo
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberKB065
    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 SponsorKEDRION S.P.A
    B.1.3.4CountryItaly
    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 supportKedrion S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKedrion S.p.A.
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressLoc. Il Ciocco, Castelvecchio Pascoli
    B.5.3.2Town/ cityBarga (LU)
    B.5.3.3Post code55051
    B.5.3.4CountryItaly
    B.5.4Telephone number+390538767324
    B.5.5Fax number+390257763793
    B.5.6E-maila.lotti@kedrion.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 IMMUNORHO
    D.2.1.1.2Name of the Marketing Authorisation holderKedrion S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameIMMUNORHO
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN ANTI-D IMMUNOGLOBULIN
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameVIRUS INACTIVATED HUMAN ANTI-D IMMUNOGLOBULIN
    D.3.9.4EV Substance CodeSUB12027MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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
    NA
    NA
    E.1.1.1Medical condition in easily understood language
    Isoimmunization of RhD negative mothers with a RhD positive foetus
    Isoimmunizzazione di madri RhD negative aventi feti RhD positivi
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10039038
    E.1.2Term Rhesus isoimmunization
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy objective: To assess the efficacy of IMMUNORHO in the prevention of Rh(D) isoimmunization in Rh(D) negative women pregnant with a Rh(D) positive foetus (including D, Dweak and Dpartial ), as measured by the incidence of anti-D antibodies at 24 weeks (corresponding to the 6 months timepoint in the EMA guideline) after last treatment administered
    Obiettivo di efficacia: valutare l'efficacia di IMMUNORHO nella prevenzione della isoimmunizzazione Rh(D) in donne in gravidanza Rh(D) negative aventi un feto Rh(D) positivo (incluso D,Dweak e Dpartial), come misurato dall'incidenza degli anticorpi anti-D a 24 settimane (corrispondenti al timepoint di 6 mesi nella lineaguida EMA) dopo l'ultimo trattamento somministrato.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy objective: To assess the efficacy of IMMUNORHO in the prevention of Rh(D) isoimmunization in Rh(D) negative women
    pregnant with a Rh(D) positive foetus (including D, Dweak and Dpartial , as measured by the incidence of anti-D antibodies at 12 weeks (corresponding to the 3 months timepoint in the EMA guideline) after last treatment administered.

    Safety Objective: To assess the safety of IMMUNORHO in the prevention of Rh(D) isoimmunization in Rh(D) negative women pregnant with a Rh(D) positive foetus (including D, Dweak and Dpartial ) from Baseline visit to 24 weeks (corresponding to 6 months) after last treatment administered

    Pharmacokinetic Objective: To characterize the pharmacokinetics (PK) of anti-D immunoglobulin after IMMUNORHO administration in Rh(D) negative pregnant women
    Obiettivo secondario di efficacia: valutare l'efficacia di IMMUNORHO nella prevenzione della isoimmunizzazione Rh(D) in donne in gravidanza Rh(D) negative aventi un feto Rh(D) positivo (incluso D,Dweak e Dpartial), come misurato dall'incidenza degli anticorpi anti-D a 12 settimane (corrispondenti al timepoint di 3 mesi nella lineaguida EMA) dopo l'ultimo trattamento somministrato.

    Obiettivo di Sicurezza: valutare la sicurezza di IMMUNORHO nella prevenzione della isoimmunizzazione Rh(D) in donne in gravidanza Rh(D) negative aventi un feto Rh(D) positivo (incluso D,Dweak e Dpartial) dalla visita baseline fino a 24 settimane (corrispondenti a 6 mesi) dopo l'ultimo trattamento ricevuto

    Obiettivo di Farmacocinetica: Caratterizzare la farmacocinetica (PK) della anti-D immunoglobulina dopo somministrazione di IMMUNORHO in donne in gravidanza Rh(D) negative.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who have voluntarily given written Informed Consent and Authorization to Access Personal Health Information after the nature of the study has been explained according to local regulatory requirements,
    prior to study entry.
    2. Age >=18 years at the time of screening.
    3. Rh(D) negative.
    4. Pregnancy is at 25 (from day 0 to day 7) to 26 (day 7) weeks gestation.
    5. Negative for anti-D antibodies.
    6. Carrying a Rh(D) positive (including Dweak and Dpartial) foetus as determined by antepartum foetal/maternal non-invasive genotyping.
    7. Individuals who can comply with study procedures.
    1. Soggetti che hanno volontariamente fornito il Consenso Informato scritto e l’Autorizzazione ad accedere alle informazioni sanitarie personali dopo che la natura dello studio è stata spiegata in accordo ai requisiti regolatori locali, prima dell’ingresso nello studio.
    2. Almeno 18 anni di età al momento dello screening.
    3. Rh(D) negativo.
    4. Gravidanza dalla 25 (da giorno 0 a giorno 7) alla 26 (giorno 7) settimana di gestazione.
    5. Negativi per anticorpi anti-D.
    6. Con un feto Rh(D) positivo (incluso Dweak e Dpartial ) come determinato da una genotipizzazione fetale/materna non invasiva.
    7. Individui che possono attenersi alle procedure dello studio.
    E.4Principal exclusion criteria
    1. Prior administration of RhD immunoglobulin during the current pregnancy.
    2. History of allergies or severe reactions to immunoglobulins or other blood products.
    3. Amniocentesis, chorionic villus biopsy, or cordocentesis performed or planned for the current pregnancy.
    4. Known clinically relevant maternal or foetal abnormality, such as placenta previa for the current pregnancy.
    5. Intra-operative cell salvage performed or planned for the current pregnancy.
    6. Blood or blood component transfusion within 6 months of study entry.
    7. Diagnosis of selective IgA deficiency with anti-IgA antibody.
    8. Participation in any interventional drug/device clinical trial within 30 days or 5 half-lives whatever is longer prior to Informed Consent.
    9. Any other medical condition that could interfere with study assessment or interpretation of the data.
    10. Multiple pregnancy.
    11. Live attenuated viral vaccine administration within 2-4 weeks before IMMUNORHO or planned within 3 months after the last administration of IMMUNORHO.
    12. History of malignancy requiring surgery, systemic therapy, or radiation within the prior 5 years or considered not in full remission (except for curatively treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ).
    13. In the opinion of the Investigator, have issues or concerns that may compromise the safety of the subject, impact the subject's compliance
    with the protocol requirements, or confound the reliability of the data acquired.
    14. Be a Kedrion, Parexel, clinical site employee, or their close relative regardless of direct involvement in research activities.
    1. Precedente somministrazione di immunoglobuline RhD nel corso della gravidanza corrente
    2. Allergie pregresse o reazioni acute alle immunoglobuline o ad altri emoderivati.
    3. Amniocentesi, biopsia dei villi coriali, o codocentesi effettuata o pianificata per la gravidanza in corso.
    4. Anomalie materne o fetali note clinicamente rilevanti, come
    placenta previa per la gravidanza in corso.
    5. Salvataggio intraoperatorio delle cellule eseguito o pianificato per la gravidanza in corso.
    6. Trasfusione sanguigna o degli emoderivati entro 6 mesi dall’ingresso nello studio.
    7. Diagnosi di deficienza selettiva IgA con anticorpi anti-IgA.
    8. Partecipazione in qualsiasi studio clinico interventistico per farmaco/dispositivo entro 30 giorni o 5 emivite in base a quale dei due intervalli temporali risulti più lungo prima del Consenso Informato.
    9. Qualsiasi altra condizione medica che potrebbe interferire con la valutazione dello studio o l’interpretazione dei dati.
    10. Gravidanza multipla.
    11. Somministrazione di vaccini di virus vivi attenuati entro 2-4 settimane prima di IMMUNORHO o pianificati entro 3 mesi dopo l’ultima somministrazione di IMMUNORHO.
    12. Pregresso tumore maligno richiedente chirurgia, terapia sistemica o radiazione entro i primi 5 anni o considerato non in piena remissione (ad eccezione ad eccezione del carcinoma a cellule basali o squamose della pelle trattato o del carcinoma cervicale curato in situ).
    13. Secondo il parere dello sperimentatore, avere problemi o preoccupazioni che potrebbero compromettere la sicurezza del soggetto, influire sulla conformità del soggetto con i requisiti del protocollo o confondere l'affidabilità dei dati acquisiti.
    14. Impiegati Kedrion, Parexel o dei centri clinici, o loro parenti stretti indipendentemente dal coinvolgimento diretto nelle attività di ricerca.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints
    Incidence of anti-D antibodies evaluated at 24 weeks (corresponding to the 6 months timepoint in the EMA guideline) after treatment (last dose received).
    Endpoint Primario di Efficacia
    Incidenza degli anti-D anticorpi valutati a 24 settimane (corrispondenti al timepoint di 6 mesi nella lineaguida EMA) dopo il trattamento (ultima dose ricevuta).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks after treatment
    24 settimane dopo il trattamento
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    Incidence of anti D antibodies evaluated at 12 weeks (corresponding to the 3 months timepoint in the EMA guideline) after treatment (last dose
    received).
    Endpoint Secondario di Efficacia
    Incidenza degli anti-D anticorpi valutati a 12 settimane (corrispondenti al timepoint di 3 mesi nella lineaguida EMA) dopo il trattamento (ultima dose ricevuta).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks after treatment
    12 settimane dopo il trattamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    Hungary
    Italy
    Poland
    Czechia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial 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: 276
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 158
    F.4.2.2In the whole clinical trial 276
    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
    Nessuno
    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 Decision2021-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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