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    Summary
    EudraCT Number:2011-006174-47
    Sponsor's Protocol Code Number:FC-004
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-04
    Trial results Removed from public view
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-006174-47
    A.3Full title of the trial
    A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Haemostasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Haemostasis
    A.3.2Name or abbreviated title of the trial where available
    FINISH-3
    A.4.1Sponsor's protocol code numberFC-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01527357
    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 SponsorProFibrix BV
    B.1.3.4CountryNetherlands
    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 supportProFibrix BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovella Clinical
    B.5.2Functional name of contact pointGrace Marsden
    B.5.3 Address:
    B.5.3.1Street AddressRichmond House
    B.5.3.2Town/ cityWalkern Road
    B.5.3.3Post codeSG1 3QP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 01438794515
    B.5.5Fax number+44 08707626257
    B.5.6E-mailgmarsden@novellaclinical.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 nameFibrocaps™
    D.3.2Product code PRO-0601
    D.3.4Pharmaceutical form Sealant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    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/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number71
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number 04/04/9002
    D.3.9.3Other descriptive nameHUMAN THROMBIN
    D.3.9.4EV Substance CodeSUB20551
    D.3.10 Strength
    D.3.10.1Concentration unit IU/g international unit(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number643
    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 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
    Intraoperative Surgical Hemostasis (Spinal Surgery, Vascular Surgery, Hepatic resection, Soft tissue dissection)
    E.1.1.1Medical condition in easily understood language
    Intraoperative surgical mild to moderate bleeding (Spinal Surgery, Vascular Surgery, Hepatic resection, Soft tissue dissection).
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10053001
    E.1.2Term Surgical haemostasis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate the superiority of Fibrocaps plus
    gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects
    undergoing spine, liver, vascular or soft tissue surgery, when control of mild to moderate
    bleeding by standard surgical techniques is ineffective and/or impractical
    E.2.2Secondary objectives of the trial
    Secondary study objectives are to further characterize the efficacy and safety profiles of
    Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, in subjects undergoing
    spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by
    standard surgical techniques is ineffective and/or impractical.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria (pre-surgery):
    1. Subject has signed an institutional review board/independent ethics committee
    (IRB/IEC)-approved informed consent document
    2. Subject is undergoing one of the surgical procedures described above
    3. Subject age is ≥18 years at time of consent
    4. If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding
    5. If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits.
    Inclusion Criteria (during surgery):
    1. Subject has not received blood transfusion between screening and study treatment.
    2. Presence of mild or moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical.
    3. Absence of intra-operative complications other than bleeding which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety.
    4. No intra-operative use of a topical hemostat containing thrombin prior to study treatment.
    5. Approximate TBS surface area of ≤ 100 cm2
    E.4Principal exclusion criteria
    Exclusion Criteria:
    1. Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors
    2. Subject has history of heparin-induced thrombocytopenia (only for vascular subjects
    where heparin use is required)
    3. Subject has known allergy to porcine gelatin
    4. Subject is unwilling to receive blood products
    5. Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator, or baseline abnormalities of INR > 2.5 or aPTT > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
    6. Aspartate Aminotransferase (ASAT/AST ) or Alanine aminotransferase (ALAT/ALT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit for these analytes due to the nature of their disease
    7. Platelets < 100 x109 PLT/L during screening
    8. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures
    9. Subject is currently participating or has participated in another clinical study involving
    another investigational agent within 4 weeks of the planned date of surgery or is planning participation in another clinical trial within 4 weeks after surgery
    E.5 End points
    E.5.1Primary end point(s)
    Time to hemostasis (TTH) within the 5-minute TTH assessment period by treatment
    group within each surgical indication.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 and 5 minutes after treatment
    Time to Haemostasis assessments made every 30 seconds from treatment application, to assess endpoint
    E.5.2Secondary end point(s)
    Efficacy: TTH-related endpoints include restricted mean TTH, and proportion of subjects achieving hemostasis within 3
    and 5 minutes by treatment group within each surgical indication. Additional endpoints include the use of alternative hemostatic agents at the TBS, transfusion requirements (RBC usage though Day 29) and re-operation at the TBS for bleeding complications by treatment group within each surgical indication.
    Safety: Overall safety, as determined by the incidence, severity and relationship of AEs,
    clinical laboratory abnormalities, estimated rates of immunogenicity and post-surgery bleeding
    complications, will be compared between treatment groups by surgical indication and overall.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 and 5 minutes after treatment
    Time to Haemostasis assessments made every 30 seconds from treatment application, to assess endpoint
    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 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 Yes
    E.8.2.3.1Comparator description
    Gelatin Sponge (Spongostan)
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Belgium
    Netherlands
    United Kingdom
    United States
    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
    4 weeks after treatment of last subject.
    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 months0
    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 months0
    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: 404
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 268
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 672
    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)
    Standard of care.
    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 Decision2012-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-25
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