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    Summary
    EudraCT Number:2011-005479-17
    Sponsor's Protocol Code Number:400-11-002
    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:2012-04-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-005479-17
    A.3Full title of the trial
    A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety and effectiveness of EVICEL® as a treatment in addition to standard techniques of joining the colon together
    A.3.2Name or abbreviated title of the trial where available
    The EVICEL® GI Study
    A.4.1Sponsor's protocol code number400-11-002
    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 SponsorEthicon Inc., a Johnson & Johnson Co.
    B.1.3.4CountryUnited States
    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 supportEthicon
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEthicon Inc., a Johnson & Johnson Co.
    B.5.2Functional name of contact pointAssoc. Dir., Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressRoute 22 West
    B.5.3.2Town/ citySomerville, New Jersey
    B.5.3.3Post code08876-0151
    B.5.3.4CountryUnited States
    B.5.4Telephone number12089182492
    B.5.5Fax number12089185490
    B.5.6E-mailjbatill2@its.jnj.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 Yes
    D.2.1.1.1Trade name EVICEL®
    D.2.1.1.2Name of the Marketing Authorisation holderOmrix Biopharmaceuticals NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEVICEL®
    D.3.4Pharmaceutical form Sealant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraabdominal use (Noncurrent)
    Topical use (Noncurrent)
    Epilesional 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 nameThrombin
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800 to 1200
    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 nameBAC 2
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 90
    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
    Gastrointestinal Anastomosis Leak
    E.1.1.1Medical condition in easily understood language
    Sealing of joined ends of the colon
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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 effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to stapled anastomosis after lower anterior resection (LAR).

    This will be done by assessing the absence of clinical anastomotic leak (success) within 40 days post operatively.

    Clinical anastomotic leak is defined as signs and symptoms that are confirmed by one or more of the following methods:
    • Confirmation on imaging;
    • Visual confirmation (eg., reoperation/drain output).
    E.2.2Secondary objectives of the trial
    - Incidence of adverse events up to post operative Day 90;
    - Incidence of clinical anastomotic leak within 90 days post operatively;
    - Incidence of stricture (up to post operative Day 90);
    - Incidence of post operative intervention related to clinical anastomotic leak or stricture (percutanous drainage, intraluminal stenting or reoperation), up to post operative Day 90.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Preoperative:
    1) Subjects undergoing primary elective lower anterior resection with a stapled end-to-end or end-to-side anastomosis;
    2) Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures;
    Intraoperative:
    3) Confirmed distance of anastomosis is ≤12cm from the anal verge, as measured using a rigid scope or non-flexible scope alternative.
    4) Anastomosis with a successful leak test.
    E.4Principal exclusion criteria
    Pre-operative:
    1) Avastin use within 30 days prior to surgery;
    2) Known hypersensitivity to the human blood products or the components of the investigational product;
    3) Female subjects who are pregnant or nursing;
    4) Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.

    Intra-operative:
    5) Subject requiring protective ostomy;
    6) Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedures.
    7) Use of any fibrin sealant for haemostasis during the surgical procedure.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects with absence of clinical anastomotic leak within 40 days post-operatively.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 40 days post-operatively.
    E.5.2Secondary end point(s)
    - Incidence of adverse events up to post operative Day 90;
    - Incidence of clinical anastomotic leak within 90 days post operatively;
    - Incidence of stricture (up to post operative Day 90);
    - Incidence of post operative intervention related to clinical anastomotic leak or stricture (percutanous drainage, intraluminal stenting or reoperation), up to post operative Day 90.
    E.5.2.1Timepoint(s) of evaluation of this end point
    76 -104 days post-operatively.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Standard of care
    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 concerned2
    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 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
    Australia
    Canada
    Korea, Republic of
    New Zealand
    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
    Day 90 visit. Althought the study is concluded after 90 days post-operatively, all subjects will be followed specifically and only to ascertain stricture information at 180 and 360 days.
    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 months4
    E.8.9.1In the Member State concerned days4
    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 days4
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 150
    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)
    Not applicable as the study drug is a once-only treatment given intra-operatively by the surgeon.
    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 Decision2012-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-06
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