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    The EU Clinical Trials Register currently displays   36117   clinical trials with a EudraCT protocol, of which   5940   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-001326-26
    Sponsor's Protocol Code Number:AA-GYN-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-06-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-001326-26
    A.3Full title of the trial
    A Prospective, Controlled, Randomized, Multi-Center, Phase I/II Study Evaluating the Safety and Efficacy of Adhexil™
    A.3.2Name or abbreviated title of the trial where available
    Using Adhexil To Prevent and/or Reduce Adhesions After Ovarian Surgery
    A.4.1Sponsor's protocol code numberAA-GYN-001
    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 SponsorOmrix Biopharmaceuticals Ltd.
    B.1.3.4CountryIsrael
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Quixil
    D.2.1.1.2Name of the Marketing Authorisation holderOmrix Biopharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameADHEXIL
    D.3.4Pharmaceutical form Sealant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraabdominal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameHUMAN THROMBIN
    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.3.9.3Other descriptive nameHuman Fibrinogen
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 60
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Patients that undergo surgery that involves the ovaries
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10033137
    E.1.2Term Ovarian cystectomy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to evaluate the safety and initial efficacy of the anti-adhesion kit (AA) AdhexilTM for the prevention and/or reduction of prospective adhesions in female patients who are undergoing a surgical procedure involving the ovaries.
    E.2.2Secondary objectives of the trial
    There are no secondary objectives for this study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Female patients aged 18-45 years at screening
    2.Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease
    3.Patients must be willing to participate in the study, and provide written informed consent
    4.Patient available and willing to undertake study visits and procedures
    5.Patients of child-bearing potential must be using a medically acceptable method of birth control throughout the study.
    6.Presence of both ovaries and both intact fallopian tubes.
    E.4Principal exclusion criteria
    1.Pregnant (including ectopic pregnancy) or breastfeeding patients
    2.Patients whose 1LL procedure would involve enterotomy and/or cystotomy and/or urostomy, and/or postoperative hydrotubation
    3.Patients whose 1LL procedure would involve surgical sterilization
    4.Patients whose 1LL procedure would involve hysterectomy
    5.Patients with a documented diagnosis of cancer
    6.Patients with a lymphatic, hematologic or coagulation disorder
    7.Known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™
    8.Patients whose pre-operative laboratory values at the baseline visit are out of normal ranges
    9.Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
    10.Patients who have participated in another clinical study within 30 days of enrolment.
    11.Investigator’s opinion that the patient is medically unfit or would be at major risk if enrolled into the study
    12.Patients with American Society of Anesthesiologists class > I

    Intra-Operative Exclusion Criteria
    1.Failure to lyse any of the existing ovarian adhesions
    2.Absence of one or both ovaries
    3.Absence of one or both Fallopian tubes
    4.Presence of active infection.
    5.Presence of malignancy
    6.Use of heparin-containing irrigants
    7.Use of other adjuvants for the purpose of reducing adhesions, including INTERCEED, SprayGel, Seprafilm, ADEPT, Hyskon, Oxiplex, corticosteroids, anticoagulants, and nonsteroidal anti-inflammatory agents.
    8.Requirement to perform enterotomy and/or cystotomy and/or urostomy and/or hysterectomy
    9.Patients who underwent a peritoneal grafting procedure
    10.Patients in whom a procedure required conversion to laparotomy
    11.Use of any topical hemostatic agents that are left behind in the body or use of catgut, chromic catgut, or nonresorbable sutures on the ovaries or immediately adjacent structures
    12.Use of gasless laparoscopy
    13.Performance of non-gynecologic surgical procedure (cholecystectomy)
    14.Investigator’s opinion that a second look is not in the best interest of the patient

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the incidence of ovaries with adhesions.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    different indication for an approved product
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Third-party blinded
    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
    Untreated ovary of the same patient (only one side will be treated)
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 EEA3
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Each patient will be treated with Adhexil and will be followed for safety and efficacy evaluations for a period of 6(+/-4) weeks after surgery (with exceptional cases at not later than 14 weeks after 1LL), and a 30 day follow up for adverse events. End of study is defined as the time of database lock, and will occur when the 30 day follow up period will be over for the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 25
    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)
    At least 30 days of 2LL (+2 days), a follow up visit will be conducted by phone and the patient will be questioned for her physical status, and for any changes in concomitant medications and any occurance of adverse events since last visit. The information will be recorded on the worksheet and in the CRF.
    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 Decision2007-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-12-21
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