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    Summary
    EudraCT Number:2016-003661-26
    Sponsor's Protocol Code Number:HX-02-PEP
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-003661-26
    A.3Full title of the trial
    A controlled, randomized, multi-centre, double blind, phase II study to evaluate efficacy and safety of topical PeproStat in intraoperative surgical haemostasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effectiveness and safety of study drug (PeproStat) to stop bleeding during surgery.
    A.3.2Name or abbreviated title of the trial where available
    CLOTFAST 2
    A.4.1Sponsor's protocol code numberHX-02-PEP
    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 SponsorHaemostatix Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportHaemostatix Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHaemostatix Limited
    B.5.2Functional name of contact pointInformation point
    B.5.3 Address:
    B.5.3.1Street AddressBioCity Nottingham
    B.5.3.2Town/ cityNottingham
    B.5.3.3Post codeNG1 1GF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441159124512
    B.5.6E-mailinfo@ergomedplc.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 namePeproStat
    D.3.4Pharmaceutical form Solution for sealant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGPRPG-rHA conjugate
    D.3.9.2Current sponsor codeHXSA902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Sodium Chloride 0.9% Intravenous Infusion BP
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Ltd
    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 nameSaline
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsaline
    D.3.9.2Current sponsor codesaline
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    To achieve haemostasis when bleeding cannot be controlled by conventional methods alone, such as manual pressure, cauterization, or sutures; or are inappropriate.
    E.1.1.1Medical condition in easily understood language
    To stop bleeding when conventional methods alone cannot stop bleeding.
    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 19.0
    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 is to evaluate the efficacy of PeproStat in intraoperative hemostasis in adult subjects who undergo open liver/soft tissue surgery, vascular surgery or spine surgery
    E.2.2Secondary objectives of the trial
    The secondary objective is to further investigate the safety of PeproStat
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is undergoing a planned open liver/soft tissue surgery, vascular surgery or spine surgery.
    2. Subjects are able and willing to provide written informed consent to participate in this study.
    3. Adult males and females ≥18 years of age at screening.
    4. Willing and able to comply with all protocol requirements including follow-up assessments.
    5. Male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow-up visit.
    6. Women of childbearing potential (WCBP) have to use highly effective methods of contraception from enrollment through to the 30 day follow-up visit. Such methods include:
    Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal.
    Progestogen-only hormonal contraception associated with inhibition of
    ovulation: oral, injectable or implantable.
    Intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence
    7. The subject presents an identified target bleeding site with mild or moderate bleeding, which conventional surgical techniques are insufficient to control or are inappropriate and would otherwise be a candidate for standard haemostats.
    8. The subject presents no intraoperative complications, other than bleeding, that may interfere with study assessments as judged by the Investigator.
    9. The subject presents no contaminated areas of the body, signs of infection or abscess development.
    10. Total target bleeding site surface area of ≤ 70 cm2, defined within one or two TBSs
    E.4Principal exclusion criteria
    1. Subject is undergoing emergency surgical procedure.
    2. Use of study treatment and sponge in
    • Closure of skin incisions as the sponge may interfere with the healing of skin edges.
    • Intravascular compartments because of the risk of embolization following sponge application.
    3. Recipient of an organ transplant.
    4. Haematologic, biochemistry and coagulation panel thresholds at screening:
    • Haemoglobin ≤ 9.0 g/dL.
    • Platelet count ≤100,000/mm3 (≤ 100 x 109/L).
    • International Normalized Ratio (INR) > 2.0 or aPTT ratio > 2.0.
    • Fibrinogen level < 1.5 g/L.
    • Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) ≥ 3 times the upper limit normal range, except for subjects undergoing liver resection surgery where there is no upper limit for these analytes due to the nature of their disease.
    5. Severe renal failure.
    6. Any other disease or condition that may affect normal blood clotting, for example thrombocytopenia, as judged by the Investigator.
    7. A known history of anaphylaxis or allergic reaction to human albumin, PEGylated proteins, yeast or moulds, porcine products or other components in the study medication or sponge.
    8. Participation in another investigational drug or device research study within 30 days before and after enrolment in the current study.
    9. Current known or suspected alcohol and/or drug abuse or dependence at the time of screening.
    10. Any concurrent medical, surgical, or psychiatric condition that may, in the Investigator’s opinion, affect the subject’s willingness or ability to meet all study requirements during the study duration.
    11. Known HIV, HBV or HCV infection.
    12. During the surgery, subject presents severe bleeding where use of a topical haemostat would be inappropriate.
    13. Anti-platelets/oral anticoagulants treatment:
    a. Soft tissue/liver and neurosurgery: Subject is taking anti-platelet agents or oral anticoagulants within 7 days of surgery.
    b. Vascular surgery: Subject is taking dual anti-platelet treatment or oral anticoagulants within 7 days of surgery. One anti-platelet agent is allowed perioperatively.
    14. Heparin treatment:
    a. Soft tissue/liver and neurosurgery only: Subject is receiving therapeutic doses of heparin perioperatively. Only prophylactic LMWH is allowed.
    15. Pregnant or breast-feeding subject.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the investigation of efficacy in terms of Time to haemostasis, mean (mTTH) at the primary target bleed site (TBS), measured in minutes (min) from the start of treatment application (TxStart) at the TBS to the achievement of haemostasis at that site or to the end of the 10-minute assessment period if haemostasis has not yet been achieved. If haemostasis is not achieved within 10 minutes at the primary TBS, the patient is considered a treatment failure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the surgery
    E.5.2Secondary end point(s)
    Secondary endpoints, efficacy:
    1. Percentage of subjects achieving hemostasis at 1, 2, 3, 5, 7 & 10 min;
    2. Median time to hemostasis in minutes from TxStart to the achievement of hemostasis or to the end of the 10-minute assessment period if hemostasis has not yet been achieved;
    3. Number/rate of subjects who do not achieve hemostasis within 10 min;
    4. Number and size (if cut to size) of sponges applied at TBS, i.e., 1 or 2 sponges at TBS;
    5. Dose of PeproStat determined by number and size of PeproStat soaked sponges applied at TBS;
    6. Number/rate of treatment failures: Subjects not having obtained hemostasis within the 10-minute assessment period (primary, secondary and both TBS);
    7. Use of alternative hemostatic agents at the TBS;
    8. Investigator assessment of efficacy to obtain haemostasis (scale of 1-5, where 5 is very effective);
    9. Investigator assessment ease of use of study treatment (score 1 – 5 where 5 is very easy to use).

    Secondary endpoints, safety:
    10. Adverse events (AEs) including adverse events of special interest: Bleeding at the TBS after 10-minute assessment period during or after surgery (if re-operation is required) and transfusion requirement;
    11. Antiplatelet/ heparin usage;
    12. Laboratory safety parameters;
    13. Immunogenicity testing;
    14. Vital signs: heart rate (HR), blood pressure (BP), respiratory rate (RR); arterial oxigenation (pulse oximetry, PO);
    15. 12-lead electrocardiogram (ECG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2,3,5,7 and 10 minutes
    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) 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 No
    E.8.1.4Double blind Yes
    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
    Saline soaked into Absorbable haemostatic 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Bosnia and Herzegovina
    Croatia
    Germany
    Poland
    Serbia
    Ukraine
    United Kingdom
    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 years0
    E.8.9.1In the Member State concerned months8
    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 months8
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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)
    Normal treatment options are available to the subject after they have finished participating in the trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-23
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