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    Summary
    EudraCT Number:2022-004132-25
    Sponsor's Protocol Code Number:F7TG2202
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-03-23
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2022-004132-25
    A.3Full title of the trial
    A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients with Congenital Hemophilia A or B with Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating the effects of coagulation factor VIIa during surgical procedure in patients with Hemophilia A or B and with inhibitors to Factor VIII or IX
    A.3.2Name or abbreviated title of the trial where available
    SCOPE HIM
    A.4.1Sponsor's protocol code numberF7TG2202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05695391
    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 SponsorLFB Biotechnologies
    B.1.3.4CountryFrance
    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 Biotechnologies
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB Biotechnologies
    B.5.2Functional name of contact pointGlobal Clinical Development Leader
    B.5.3 Address:
    B.5.3.1Street Address3 Avenue des Tropiques - BP 40305
    B.5.3.2Town/ cityCOURTABOEUF Cedex
    B.5.3.3Post code91958
    B.5.3.4CountryFrance
    B.5.4Telephone number33169827010
    B.5.6E-mailcarbonnellee@lfb.fr
    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 CEVENFACTA
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Francais du Fractionnement et des Biotechnologies
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEptacog beta (activated)
    D.3.9.2Current sponsor codeLR769
    D.3.9.4EV Substance CodeSUB213738
    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 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 Yes
    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
    Prevention of excessive bleeding in haemophilia A or B subjects with inhibitors undergoing major surgical procedures
    E.1.1.1Medical condition in easily understood language
    Prevent and stop bleeding during and after a major surgical intervention in patients with haemophilia A or B having antibodies against the standard treatment
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the efficacy of Eptacog Beta (activated) in terms of achieving and maintaining hemostasis in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX undergoing elective major surgical procedures
    E.2.2Secondary objectives of the trial
    Assess the safety of Eptacog Beta (activated)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - be male with a diagnosis of congenital hemophilia A or B of any severity
    - have one of the following:
    a. current positive inhibitor test BU ≥5 (as confirmed at screening by the institutional lab) or history of high-responding inhibitors (BU ≥5) not further successfully treated by Immune Tolerance Induction OR

    b. a condition precluding the use of FVIII or FIX products to treat or prevent bleeding such as a previous anamnestic response after exposure to factor concentrates or a previous failure to respond to FVIII or FIX concentrates
    - be ≥12 years to ≤65 years of age
    - be scheduled for an elective major surgical procedure
    - have Hb ≥12 g/dL
    - patient's and/or parent(s)'/legal guardian(s)' understanding and willingness to comply with the conditions of the protocol
    written informed consent
    E.4Principal exclusion criteria
    - have any coagulation disorder other than hemophilia A or B
    be immunosuppressed (CD4+ cell counts at screening should be 200/μL)
    - known intolerance to Eptacog Beta (activated) or any of its excipients
    - currently receiving immune tolerance induction (ITI) therapy
    - have a known or suspected allergy or hypersensitivity to rabbits or rabbit proteins
    - have platelet count <100,000/μL
    - have received an investigational drug within 30 days or within 5 half-lives of that investigational drug, whichever is longer, of the planned first Eptacog Beta (activated) administration, or be expected to receive such drug during participation in this study. Patients who - - have received fitusiran in a clinical study may not participate in this clinical study for 6 months since the last dose and if they have an antithrombin III level not in the normal range at screening.
    - for patients using emicizumab, have received during the last 6 months or currently receiving a maintenance dosing regimen of emicizumab different from the indicated one (±10% of approved dose), i.e. different from 1.5 mg/kg once weekly (±10%), 3 mg/kg (±10%) every two weeks or 6 mg/kg (±10%) every four weeks
    - for patients using emicizumab, currently be any plans, or notes in the patient’s medical records that would suggest the need to increase or decrease emicizumab dosing due to antidrug antibodies (ADAs), reduced PK, or coagulation/safety-related issues (e.g. lack of response, or potential/actual thromboembolic concerns, etc)
    - 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)
    - have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, DVT, or PE) within 2 years prior to the planned first dose of Eptacog Beta (activated), uncontrolled arrhythmia, or current NYHA functional classification score of stages II – IV
    - have an active malignancy (those with non-melanoma skin cancer are allowed)
    - have any life-threatening disease or other disease or condition which, according to the investigator’s judgment, could imply a potential hazard to the patient, or interfere with the study participation or study outcome (e.g. chronic, unmanaged hepatitis infection)
    - be using aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), herbs, natural medications, or other drugs with platelet inhibitory properties within one week prior to surgery and for the duration of treatment with Eptacog Beta (activated)
    - have active gastric or duodenal ulcer disease
    - have received a FVII- or FVIIa-containing product (either plasma derived or recombinant) within 24 hours prior to administration of Eptacog Beta (activated)
    - have a contraindication to antifibrinolytics
    - have planned combined major surgeries at the same time or have already been enrolled and treated for a previous elective major surgery in the same SCOPE HIM study
    - be administered pharmacologic thromboprophylaxis within 5 half-lives of that medication before surgery or for the duration of treatment with Eptacog Beta (activated)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of successfully treated major procedures defined by a good or excellent global hemostatic response obtained by summing assigned scores from a defined 4-point hemostatic scale determined at wound closure (T0), at 24 hours after surgical wound closure, and at 120 hours after surgical wound closure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At wound closure (T0) (based on data collected during the intraoperative period)
    At 24 hours after surgical wound closure (based on data collected during the 24-hour postoperative period, i.e. 0-24 hours period)
    At 120 hours after surgical wound closure (based on data collected during the 120-hour postoperative period, i.e. 0-120 hours)
    E.5.2Secondary end point(s)
    - Proportion of successfully treated major procedures defined by a good or excellent hemostatic response based on the 4-point hemostatic scale at each of the reference timepoints
    - Proportion of successfully treated major procedures defined by a good or excellent global hemostatic response based on the 4-point hemostatic scale as assessed by the investigator at subsequent days
    - Mean difference between actual measurable intraoperative blood loss and maximum predicted blood loss in a similar patient without a bleeding disorder for the same major procedure
    - Mean difference between actual measurable pstoperative blood loss (measured by the amount of drainage in mL where, and for the duration, drain is needed) and maximum predicted blood loss in a similar patient without a bleeding disorder for the same major procedure at each of the reference timepoints
    - Mean difference between actual blood product transfusion and maximum predicted blood product transfusion in mL in a similar patient without a bleeding disorder for the same major procedure at each of the reference timepoints
    - Mean change in Hemoglobin level from initiation of the surgery until last visit
    - Mean amount of Eptacog Beta (activated) used to maintain hemostasis during surgery and post-surgery
    - Mean number of bleeding episodes at the surgical site between surgical wound closure and last visit
    - Mean number of surgical interventions/re-explorations for bleeding episodes between surgical wound closure and last visit
    - Number of deaths from bleeding attributed to ineffective hemostasis
    - Number and incidence of TEAEs (i.e. all AEs that occur at the time of or after the IMP administration until follow-up phone call) and AESIs (i.e. thromboembolic events and hypersensitivity reactions)
    - Mean value at each timepoint and mean change from baseline to each post-baseline timepoint in clinical laboratory parameters (continuous); proportion for each response category at each timepoint and proportion for each response category shift from baseline to each post-baseline timepoint in clinical laboratory parameters (discrete)
    - Mean value at each timepoint and mean change from baseline to each post-baseline timepoint in vital signs
    - Proportion for each response category at each timepoint and proportion for each response category shift from baseline to each post-baseline timepoint in physical examination
    - Mean value at each visit and mean change from baseline to each visit in coagulation-related parameters (fibrinogen and D-dimer levels)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At wound closure (T0) (based on data collected during the intraoperative period)
    At 24 hours after surgical wound closure (based on data collected during the 24-hour postoperative period, i.e. 0-24 hours period)
    At 120 hours after surgical wound closure (based on data collected during the 120-hour postoperative period, i.e. 0-120 hours)
    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 No
    E.8.1.1Randomised No
    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 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.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Malaysia
    Mexico
    South Africa
    Thailand
    United States
    Türkiye
    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
    Last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    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: 2
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 19
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Orthopaedic Institute for Children - Orthopaedic Hemophilia Treatment Center
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Children's Healthcare of Atlanta
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Tulane Univertsity School of Medecine
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation M Health Fairview Center for bleeding and Clotting disorders
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation University of Texas Health Science Center at Houston
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Hospital Queen Elisabeth - Kota Kinabalu
    G.4.3.4Network Country Malaysia
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation Hospital Ampang
    G.4.3.4Network Country Malaysia
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation Hospital Universitario Dr. José Eleuterio González de Nuevo León
    G.4.3.4Network Country Mexico
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation Charlotte Maxeke Johannesburg Academic Hospital
    G.4.3.4Network Country South Africa
    G.4 Investigator Network to be involved in the Trial: 10
    G.4.1Name of Organisation Chiang Mai University
    G.4.3.4Network Country Thailand
    G.4 Investigator Network to be involved in the Trial: 11
    G.4.1Name of Organisation Maharaj Nakorn Chiangmai Hospital, Chiangmai University
    G.4.3.4Network Country Thailand
    G.4 Investigator Network to be involved in the Trial: 12
    G.4.1Name of Organisation Acibadem Adana Hospital
    G.4.3.4Network Country Türkiye
    G.4 Investigator Network to be involved in the Trial: 13
    G.4.1Name of Organisation Hacettepe Üniversitesi Rektörlüğü Sihhiye
    G.4.3.4Network Country Türkiye
    G.4 Investigator Network to be involved in the Trial: 14
    G.4.1Name of Organisation Istanbul Üniversitesi Onkoloji Enstitusu
    G.4.3.4Network Country Türkiye
    G.4 Investigator Network to be involved in the Trial: 15
    G.4.1Name of Organisation Karadeniz Teknik Üniversitesi
    G.4.3.4Network Country Türkiye
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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