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    Summary
    EudraCT Number:2015-000958-38
    Sponsor's Protocol Code Number:LFB-FVIIa-007-14
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-09-03
    Trial results View 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 number2015-000958-38
    A.3Full title of the trial
    A Phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients from birth to <12 years old with Inhibitors to Factor VIII or IX: PerSept 2
    Studio di fase III sulla sicurezza, la farmacocinetica e l'efficacia del fattore VIIa (ricombinante)
    della coagulazione in pazienti pediatrici di et¿ da 0 mesi a <12 anni affetti da emofilia congenita A
    o B con inibitori verso il fattore VIII o IX: PerSept 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study with a Factor VIIa (Recombinant) to evaluate its efficacy, its safety and its behaviour in human blood in pediatric patients from birth to less than 12 years of age with Hemophilia A or B with inhibitors to factor VIII or IX
    Studio clinico del fattore VIIa (ricombinante) per valutare la sua efficacia, sicurezza e il suo comportamento nel sangue umano in pazienti pediatrici di et¿ da 0 mesi a <12 anni con emofilia A o B con inibitori del fattore VIII o IX
    A.3.2Name or abbreviated title of the trial where available
    PerSept 2
    PerSept 2
    A.4.1Sponsor's protocol code numberLFB-FVIIa-007-14
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02448680
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/106/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLFB USA, INC.
    B.1.3.4CountryMicronesia, Federated States of
    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 supportLFB USA, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB USA, Inc.
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address175 Crossing Boulevard
    B.5.3.2Town/ cityFramingham
    B.5.3.3Post codeMA 01702
    B.5.3.4CountryUnited States
    B.5.4Telephone number0015083705258
    B.5.5Fax number001 5083703797
    B.5.6E-mailmargaret.carini@lfb-usa.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 No
    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 nameCoagulation Factor VIIa (Recombinant)
    D.3.2Product code LR769
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000026-55-3
    D.3.9.2Current sponsor codeLR769
    D.3.9.4EV Substance CodeSUB13812MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Congenital Hemophilia A or B with inhibitors to Factor VIII or Factor IX
    Emofilia congenita A o B con inibitori verso il fattore VIII o IX
    E.1.1.1Medical condition in easily understood language
    Hereditary hemophilia which is caused by a shortage of Factor VIII (Hemophilia A) or Factor IX (Hemophilia B), which is complicated by
    inhibitors to factor treatment, making this ineffective
    Emofilia ereditaria che ¿ causata da una carenza di Fattore VIII (Emofilia A) o il fattore IX (emofilia B), che ¿ complicata da inibitori del fattore trattamento, rendendo questo inefficace
    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 10056492
    E.1.2Term Haemophilia A with anti factor VIII
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10056494
    E.1.2Term Haemophilia B with anti factor IX
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of 2 separate dose regimens (75 ¿g/kg and 225 ¿g/kg) of LR769 for the treatment of bleeding episodes in hemophilia A or B pediatric patients, from birth to <12 years old, with inhibitors to factor VIII or IX
    To assess the safety of LR769, including the immunogenic potential of the drug product
    Valutare l'efficacia di 2 distinti regimi di dosaggio (75 ¿g/kg e 225 ¿g/kg) di LR769 per il
    trattamento degli episodi emorragici in pazienti pediatrici di et¿ da 0 mesi a <12 anni affetti da
    emofilia A o B con inibitori verso il fattore VIII o IX.
    Valutare la sicurezza di LR769, ivi compreso il potenziale immunogenico del farmaco.
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetics (PK) of LR769 in hemophilia A or B pediatric patients, from birth to <12 years old, with inhibitors to factor VIII or IX, without a current bleeding episode
    Valutare la farmacocinetica (Pharmacokinetics, PK) di LR769 in pazienti pediatrici di et¿ da 0 mesi a <12 anni affetti da emofilia A o B, con inibitori verso il fattore VIII o IX, in assenza di un episodio emorragico in corso.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. be male with a diagnosis of congenital hemophilia A or B of any severity
    2. have one of the following:
    a. a positive inhibitor test BU =5, OR
    b. a BU <5 but expected to have a high anamnestic response to FVIII or FIX, as demonstrated from the patient’s medical history, precluding the use of factor
    VIII or IX products to treat bleeding episodes, OR
    c. a BU <5 but expected to be refractory to increased dosing of FVIII or FIX, as demonstrated from the patient’s medical history, precluding the use of factor VIII or IX products to treat bleeding episodes
    3. be aged from birth to <12 years old
    4. have experienced at least 3 bleeding episodes of any severity in the past 6 months; if < 6 months old, have experienced at least 3 bleeding episodes since birth
    5. parents or legal guardians must be capable of understanding and be willing to comply with the conditions of the protocol
    6. parents or legal guardians must have read, understood, and provided written informed consent
    1. essere di sesso maschile e affetti da emofilia congenita A o B di qualsiasi gravità;
    2. soddisfare uno dei seguenti criteri:
    a. test positivo per gli inibitori con livello BU =5, OPPURE
    b. livello BU <5 ma con forte risposta anamnestica prevista al FVIII o al FIX, come dimostrato dall'anamnesi medica del paziente, il che preclude l'uso di prodotti a base di fattore VIII o XI per il trattamento degli episodi emorragici, OPPURE
    c. livello BU <5 ma refrattari ad un dosaggio maggiore del FVIII o del FIX, come dimostrato dall'anamnesi medica del paziente, il che preclude l'uso di prodotti a base di fattore VIII o XI per il trattamento degli episodi emorragici.
    3. avere un'età da 0 mesi a <12 anni;
    4. aver sperimentato almeno 3 episodi emorragici di qualsiasi gravità negli ultimi 6 mesi o, se
    hanno un’età <6 mesi, almeno 3 episodi emorragici dalla nascita;
    5. capacità da parte dei genitori o dei tutori legali di comprendere le condizioni del protocollo e volontà di rispettarle;
    6. lettura, comprensione e firma del consenso informato scritto da parte dei genitori o dei tutori legali.
    E.4Principal exclusion criteria
    1. have any coagulation disorder other than hemophilia A or B
    2. be immunosuppressed (i.e., the patient may not be receiving systemic immunosuppressive medication; CD4 counts at screening must be >200/µL)
    3. have a known allergy or hypersensitivity to rabbits
    4. have platelet count <100,000/µL
    5. have had a major surgical procedure (e.g. orthopedic, abdominal) within 1 month prior to first administration of study drug
    6. have received an investigational drug within 30 days of first study drug administration, or be expected to receive such drug during participation in this study
    7. have a clinically relevant hepatic (aspartate aminotransferase [AST] and/or alanine
    aminotransferase [ALT] >3 times the upper limit of normal [ULN]) and/or renal impairment (creatinine >2 times the ULN)
    8. have an active malignancy (those with non-melanoma skin cancer are allowed)
    9. have any life-threatening disease or other disease or condition which, in the investigator’s judgment, could pose a potential hazard to the patient or interfere with the trial participation or trial outcome (e.g., a history of non-responsiveness to
    bypassing products or thromboembolic disease)
    10. known or suspected hypersensitivity to the active substance or to any of its excipients
    1. sono affetti da qualsiasi disturbo della coagulazione diverso dall'emofilia A o B;
    2. sono immunodepressi (ovvero, non possono ricevere farmaci immunosoppressori sistemici; le conte CD4 allo screening devono essere >200/µl);
    3. presentano allergia o ipersensibilità nota ai conigli;
    4. presentano una conta piastrinica <100.000/µL;
    5. hanno subito un intervento chirurgico maggiore (ad es. ortopedico o addominale) entro 1 mese prima della prima somministrazione del farmaco in studio;
    6. hanno ricevuto un farmaco sperimentale nei 30 giorni precedenti alla prima somministrazione del farmaco in studio o si prevede che lo ricevano durante la partecipazione alla ricerca ivi descritta;
    7. sono affetti da insufficienza clinicamente rilevante di natura epatica (aspartate aminotransferasi [AST] e/o alanina aminotransferasi [ALT] >3 volte rispetto al limite superiore della norma [ULN]) e/o renale (creatinina >2 volte superiore all'ULN);
    8. sono affetti da neoplasia maligna attiva (sono ammessi i pazienti con tumore cutaneo diverso dal melanoma);
    9. sono affetti da qualsiasi patologia potenzialmente letale o da altra malattia o condizione che, secondo il parere dello sperimentatore, può costituire un rischio potenziale per il paziente o interferire con la partecipazione alla sperimentazione o l'esito dello studio (ad es. anamnesi di assenza di risposta a prodotti bypassanti o di malattia tromboembolica).
    10. ipersensibilità nota o accertata al principio attivo o a qualcuno dei suoi eccipienti
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is defined as successful treatment of a bleeding episode at 12 hours after first administration of the study drug. The following are clarification definitions to satisfy regulatory requirements in multiple regions (i.e., the FDA and the EMA).
    Definition of the primary efficacy endpoint for the FDA: the successful treatment of a bleeding episode at 12 hours after first administration of the study drug. For primary efficacy endpoint for the FDA, only treatment of mild/moderate bleeding episodes is taken into account. Severe bleeding episodes will be a minority of the bleeding episodes treated in the study, and will require treatment even if the bleeding has improved. Efficacy in severe bleeding episodes will be described separately. For primary efficacy endpoint for the FDA, successful treatment of a bleeding episode is defined as a combination of the following:
    • Good or Excellent response noted by patient/parent/guardian, depending on patient’s age and maturity
    • Study drug treatment: No further treatment with study drug beyond timepoint where a Good or Excellent response for this bleeding episode was noted
    • No other hemostatic treatment needed for this bleeding episode
    • No administration of blood products indicating continuation of bleeding beyond timepoint where a Good or Excellent response for this bleeding episode was noted
    • No increase of pain beyond timepoint where a Good or Excellent response for this bleeding episode was noted that cannot be explained other than as continuation of bleeding
    Definition of the primary efficacy endpoint for EMA: the proportion of bleeding episodes (mild/moderate and severe combined) with a “good” or “excellent” patient (for mild/moderate bleeding episodes) and physician (for severe bleeding episodes) reported assessment of efficacy at 12 hours after the first administration of study drug.
    L’endpoint primario di efficacia è la risoluzione di un episodio emorragico 12 ore dopo la prima
    somministrazione del farmaco in studio. Di seguito sono riportate delle definizioni di chiarimento
    volte ad ottemperare ai requisiti regolatori in diverse regioni (ovvero ai requisiti dell’FDA e
    dell’EMA).
    Definizione dell’endpoint primario di efficacia per l’FDA: è la risoluzione di un episodio
    emorragico dopo 12 ore dalla prima somministrazione del farmaco in studio. Per il suddetto
    endpoint per l’FDA, verrà preso in considerazione solo il trattamento degli episodi emorragici
    lievi/moderati. Nell'ambito del presente studio, gli episodi emorragici gravi verranno trattati in
    misura minoritaria e richiederanno dei trattamenti anche qualora l'emorragia migliori. L'efficacia
    relativa agli episodi emorragici gravi verrà descritta separatamente. Nell'ambito del dell’endpoint
    primario di efficacia per l’FDA, per risoluzione di un episodio emorragico si intende la
    combinazione dei seguenti criteri:
    • Risposta buona o eccellente osservata dal paziente/genitore/tutore a seconda dell’età e della
    maturità del paziente;
    • Trattamento con il farmaco in studio: nessun ulteriore trattamento con il farmaco in studio
    oltre il punto temporale in cui era stata osservata una risposta buona o eccellente per tale episodio emorragico;
    • Nessun ulteriore trattamento emostatico necessario per l'episodio emorragico;
    • Nessuna somministrazione di prodotti ematici indicante il prosieguo dell'emorragia oltre il
    punto temporale in cui era stata osservata una risposta buona o eccellente per tale episodio
    emorragico;
    • Nessun aumento del dolore oltre il punto temporale in cui era stata osservata una risposta
    buona o eccellente per tale episodio emorragico, che possa essere attribuito unicamente alla
    prosecuzione dell'emorragia.
    Definizione dell’endpoint primario di efficacia per l’EMA: è la percentuale degli episodi
    emorragici (combinazione di episodi lievi/moderati e gravi) associati ad una valutazione di
    efficacia "buona" o "eccellente" riferita dal paziente (per gli episodi emorragici lievi/moderati)
    e dal medico (per quelli gravi) 12 ore dopo la prima somministrazione del farmaco in studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time point for the primary evaluation of efficacy will be at 12 hours after first administration of study drug
    dopo 12 ore dalla prima somministrazione del farmaco in studio
    E.5.2Secondary end point(s)
    Proportion of mild/moderate bleeding episodes successfully treated, according to the same criteria as the primary endpoint of efficacy, at all other timepoints; Proportion of bleeding episodes (mild/moderate and severe, separately and combined) with a "good" or "excellent" patient (and/or physician when available) reported assessment of the efficacy at all
    timepoints; Time to assessment of a "good" or "excellent" response of the bleeding episodes (mild/moderate and severe, separately and combined) by the patient (and/or physician when available); Descriptive analysis of the number of administrations and total amount of drug administered per bleeding episode
    Percentuale di episodi emorragici lievi/moderati trattati efficacemente, in base ai medesimi criteri degli endpoint primari di efficacia, in tutti gli altri punti temporali; Percentuale di episodi emorragici (lievi/moderati e gravi, separatamente e congiuntamente) associati ad una valutazione di efficacia "buona" o "eccellente" riferita dal paziente (e/o dal medico, laddove disponibile) in tutti i punti temporali; Tempo alla valutazione relativa ad una risposta "buona" o "eccellente" degli episodi emorragici (lievi/moderati e gravi, separatamente e congiuntamente) riferita dal paziente (e/o dal medico, laddove disponibile); Analisi descrittiva della quantit¿ di somministrazioni e del volume totale di farmaco somministrato per episodio emorragico
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of study; At the end of study; At the end of study; At the end of study
    Alla fine dello studio; Alla fine dello studio; Alla fine dello studio; Alla fine dello studio
    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 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 Yes
    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 No
    E.8.1.6Cross over Yes
    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
    Stesso IMP a dosaggio diverso
    Same IMP at different dose regimen
    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.8.4.1Number 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 EEA7
    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
    Colombia
    Mexico
    South Africa
    Turkey
    Ukraine
    United States
    Bulgaria
    France
    Hungary
    Italy
    United Kingdom
    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 months2
    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 Yes
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 1
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 22
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 24
    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)
    N/A
    N/A
    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 Decision2015-11-13
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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