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    Summary
    EudraCT Number:2013-005128-40
    Sponsor's Protocol Code Number:IG1102
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-24
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-005128-40
    A.3Full title of the trial
    A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Parenchymous Tissue Open Surgeries
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety and efficacy of Fibrin Sealant Grifols (FS Grifols) in Hepatic Surgery
    A.4.1Sponsor's protocol code numberIG1102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01754480
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 Vallès
    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 fibrin sealant Grifols
    D.3.4Pharmaceutical form Solution for sealant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpilesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Thrombin
    D.3.9.1CAS number 9002-04-4
    D.3.9.3Other descriptive nameHUMAN THROMBIN
    D.3.9.4EV Substance CodeSUB20551
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.3.9.3Other 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 number80
    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
    Treatment of haemorrhage resulting from parenchymous tissue surgical procedure
    E.1.1.1Medical condition in easily understood language
    Treatment of bleeding resulting from liver surgery
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and the hemostasis efficacy of human plasma-derived fibrin sealant Grifols (FS Grifols) in parenchymous tissue surgery
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Sign the written informed consent form (ICF). For pediatric patients, a parent or legal guardian must sign ICF.
    2.Are male or female.
    3.No lower or upper age limit.
    4.Must have hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline.
    5.Require an elective (non-emergency), open (non-laparoscopic) hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
    -Where Target Bleeding Site is identified on the cut raw liver surface (resection area).
    6.Intra-operative inclusion criteria: a TBS can be identified according to the investigator’s judgment, and
    -The TBS has moderate bleeding according to the investigator’s judgment.
    E.4Principal exclusion criteria
    1.Require hepatic resection due to trauma.
    2.Have an infection in the anatomic surgical area.
    3.Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived (human or animal) product.
    4.Have previous known sensitivity to any FS Grifols component or any Surgicelīƒĸ component.
    5.(This exclusion criterion is removed).
    6.Are unlikely to adhere to the protocol requirements, or to be cooperative during the study conduct.
    7.Are females who are pregnant or nursing a child at Baseline.
    8.Are receiving an organ transplant during the same surgical procedure.
    9.Are undergoing another concurrent major surgical intervention beyond the liver.
    10.Are currently participating or have participated in another clinical study in the context of which have received an investigational drug or device within 3 months from the screening visit, or are scheduled to participate during the course of this study.
    11.Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
    12.Were previously enrolled in clinical trials with FS Grifols.
    13.Intra-operative exclusion criteria:
    -A TBS cannot be identified according to the investigator’s judgment.
    -The TBS has a mild or severe bleeding according to the investigator’s judgment.
    -Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
    -Application of any topical haemostatic material on the resection surface of the liver prior to application of the study treatment.
    -Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary haemostatic treatment.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving haemostasis at the TBS by four (4) minutes after the start of treatment application.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Four (4) minutes after the start of treatment application (T4).
    E.5.2Secondary end point(s)
    1.Time to hemostasis (TTH)
    TTH is measured from the start of treatment application at the TBS to achievement of hemostasis at that site, or to the end of the 10-minute observational period when hemostasis has not yet been achieved. This secondary efficacy endpoint will be quantified in minutes.
    2.Cumulative proportion of subject achieving hemostasis at the TBS at each of the defined time points.
    3.Prevalence of treatment failures. The following cases will be considered as treatment failures:
    -In a case of persistent bleeding at the TBS beyond the 4-minute timepoint.
    -In the event of breakthrough (brisk and forceful) bleeding at the TBS that jeopardizes subject safety, according to the investigator’s judgment, at any moment during the 10-minute observational period and until the completion of the surgical closure by layers of the exposed surgical field containing the TBS.
    -In case of re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until the completion of the surgical closure by layers of the exposed surgical field containing the TBS.
    -Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until the completion of the surgical closure by layers of the exposed surgical field, or use of allocated study treatment at the TBS beyond the assessment of the primary efficacy endpoint at T4 and until the completion of the surgical closure by layers of the exposed surgical field containing the TBS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two (2), three (3), four (4), five (5), seven (7), ten (10) minutes after the start of treatment application.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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
    Commercially available oxidized cellulose pads (Surgicel®)
    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 concerned3
    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 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
    Hungary
    Russian Federation
    Serbia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days22
    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: 90
    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: 2
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 42
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 340
    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 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 state220
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 736
    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)
    There is no planned special treatment or care after subject participation in the study apart from routine clinical practise
    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 Decision2014-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-28
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