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    Summary
    EudraCT Number:2018-004005-81
    Sponsor's Protocol Code Number:GC1801
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-09-29
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2018-004005-81
    A.3Full title of the trial
    A prospective, multicenter, open-label, single-arm study to evaluate the efficacy and safety of human plasma-derived fibrinogen concentrate (FIB Grifols) in subjects with congenital afibrinogenaemia and
    severe hypofibrinogenemia requiring either on-demand treatment for acute bleeding or surgical prophylaxis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 study to evaluate the efficacy and safety of human plasma-derived fibrinogen concentrate (FIB Grifols) in subjects with congenital afibrinogenaemia and severe hypofibrinogenemia
    A.4.1Sponsor's protocol code numberGC1801
    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 SponsorInstituto Grifols, S.A.
    B.1.3.4CountrySpain
    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 supportInstituto Grifols, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Grifols, S.A.
    B.5.2Functional name of contact pointDepartment of Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAv. Generalitat 152
    B.5.3.2Town/ citySant Cugat del valles (Barcelona)
    B.5.3.3Post code08174
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935712000
    B.5.6E-mailIGregulatory.affairs@grifols.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 nameHuman plasma-derived fibrinogen concentrate (FIB Grifols)
    D.3.2Product code FIB Grifols
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    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.3.8INN - Proposed INNHuman Fibrinogen
    D.3.9.1CAS number 9001-32-5
    D.3.9.2Current sponsor codeGC1801
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 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
    Congenital Afibrinogenaemia and Severe Hypofibrinogenemia
    E.1.1.1Medical condition in easily understood language
    Deficiency of fibrinogen in human plasma and a decreased fibrinogen concentration with milder symptoms
    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 LLT
    E.1.2Classification code 10052651
    E.1.2Term Afibrinogenaemia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To clinically evaluate the hemostatic efficacy of FIB Grifols in on-demand treatment of all documented acute bleeding episodes and in perioperative management of bleeding during and after all documented surgical procedures in subjects with congenital fibrinogen deficiency as determined by the Independent Endpoint Adjudication Committee (IEAC).
    E.2.2Secondary objectives of the trial
    -To evaluate the hemostatic efficacy of FIB Grifols in on-demand treatment of the first documented acute bleeding episode and in perioperative management of bleeding during and after the first documented surgical procedure in subjects with congenital fibrinogen deficiency as determined by the IEAC.
    -To evaluate the hemostatic efficacy of FIB Grifols in on-demand treatment of the first acute bleeding episode and all acute bleeding episodes in subjects with congenital fibrinogen deficiency as determined by the principal investigator at each trial site.
    -To evaluate the hemostatic efficacy of FIB Grifols in perioperative management of bleeding during all surgical procedures in subjects with congenital fibrinogen deficiency as determined by the surgeon.
    -To evaluate the hemostatic efficacy of FIB Grifols in perioperative management of bleeding after all surgical procedures in subjects with congenital fibrinogen deficiency as determined by the principal investigator.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject between 6 to 70 years of age.
    2. Signed and dated written ICF, or the subject’s parent or legal guardian signs and dates the ICF where applicable, and the Subject Authorization Form (SAF) where applicable.Pediatric subjects, as defined by local regulations, will be asked to sign an age appropriate assent form.
    3. Diagnosed with congenital fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia (fibrinogen <50 mg/dL) and expected to require treatment for acute bleeding (either spontaneous or after trauma [defined as any accidental event leading to acute bleeding]), or prophylaxis of bleeding before a surgical intervention or invasive procedure.
    4. Fibrinogen level < 50 mg/dL determined by Clauss method at baseline (sample drawn within 24 hours prior to infusion on Infusion 1 Day 1 Visit).
    5. Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at baseline (sample drawn within 24 hours prior to infusion on Infusion 1 Day 1 Visit).
    a. Female subjects/partners of child-bearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (eg, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal (post menopausal is defined as amenorrhea for >12 consecutive months or women on hormone replacement therapy with documented serum follicle stimulating hormone level <35 mIU/mL). Even women who are using oral, implanted or injectable contraceptive hormones, mechanical products such as an intrauterine device [IUD], or barrier methods (eg, diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy), should be considered to be of child bearing potential.
    6. Willing to comply with all aspects of the clinical trial protocol, including blood sampling, for the entire duration of the study.
    E.4Principal exclusion criteria
    1. Has acquired (secondary) fibrinogen deficiency.
    2. Diagnosed with dysfibrinogenemia.
    3. Has known antibodies against fibrinogen.
    4. Has history of anaphylaxis or severe systemic response to any drug or blood-derived product.
    5. Has history of intolerance to any component of the IP.
    6. Documented history of immunoglobulin A (IgA) deficiency and antibodies against IgA.
    7. Is a female who is pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (eg, oral, injectable, or implantable hormonal methods of contraception, placement of an IUD or intrauterine system,condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinance ) throughout the study.
    a. True abstinance: when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinance [eg, calendar, ovulation, symptothermal,post-ovulation methods], declaration of abstinance for the duration of a trial, and withdrawal are not acceptable methods of contraception.
    8. Has any medical condition which is likely to interfere with the evaluation of the IP and/or the satisfactory conduct of the clinical trial according to the investigator’s
    judgment.
    9. Has congenital or acquired bleeding disorders other than congenital fibrinogen deficiency.
    10. Has life expectancy of less than 6 months.
    11. Received FRT within 21 days prior to the Screening Visit.
    12. Receiving, or having received within 3 months prior to the Screening Visit of this clinical trial, any investigational drug or device.
    13. Is unlikely to adhere the protocol requirements, or is likely to be uncooperative, or unable to provide a storage sample prior to IP infusion.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the overall clinical assessment of the hemostatic efficacy of FIB Grifols in treating all documented acute bleeding episodes or in preventing excessive bleeding during and after all documented surgical procedures according to a 4-point scale. Hemostatic efficacy will be rated as excellent, good, moderate, or none. The primary efficacy endpoint will be assessed by the IEAC.
    E.5.2Secondary end point(s)
    - Overall clinical assessment of the hemostatic efficacy of FIB Grifols in treating the first documented acute bleeding episode or in preventing excessive bleeding during and after the first documented surgical procedure according to a 4 point scale . This secondary efficacy endpoint will be assessed by the IEAC.
    - Overall clinical assessment of the hemostatic efficacy of FIB Grifols in treating the first acute bleeding episode as assessed by the principal investigator at each trial site according to a 4-point scale.
    - Overall clinical assessment of the hemostatic efficacy of FIB Grifols in treating all acute bleeding episodes as assessed by the principal investigator at each trial site according to a 4-point scale.
    - Clinical assessment of the hemostatic efficacy of FIB Grifols in preventing excessive bleeding intra-operatively for all surgical procedures as assessed by the surgeon (defined as the licensed medical professional performing the invasive procedure [eg, dentist]) according to a 4-point scale .
    - Clinical assessment of the hemostatic efficacy of FIB Grifols in preventing excessive bleeding after all surgical procedures (ie, post-operative) as assessed by the principal investigator at each trial site according to a 4-point scale.
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    India
    Lebanon
    Turkey
    United Kingdom
    United States
    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
    Last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 32
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric Patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 32
    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)
    Patients will return to their standard of care treatment as deemed necessary for the indication by their treating physician.
    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 Decision2021-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-01-12
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