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    Summary
    EudraCT Number:2015-000301-40
    Sponsor's Protocol Code Number:009531
    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:2015-11-30
    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 number2015-000301-40
    A.3Full title of the trial
    A randomised, blinded, placebo-controlled Phase 2a study to evaluate the safety and efficacy of Artesunate treatment in severely injured trauma patients with traumatic haemorrhage.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trauma Organ Protection - Artesunate
    A.3.2Name or abbreviated title of the trial where available
    Trauma Organ Protection - Artesunate (TOP-ART)
    A.4.1Sponsor's protocol code number009531
    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 SponsorQueen Mary University of London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Wellcome Trust Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBlizard Institute, Queen Mary University London
    B.5.2Functional name of contact pointHead of Operations, Trauma Sciences
    B.5.3 Address:
    B.5.3.1Street Address4 Newark Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeE1 2AT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02078826175
    B.5.6E-mails.eaglestone@qmul.ac.uk
    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 nameArtesunate 10mg/ml
    D.3.2Product code ST7570
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNArtesunate
    D.3.9.1CAS number 88495-63-0
    D.3.9.2Current sponsor codeST7570
    D.3.9.3Other descriptive nameArtesunic acid
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Organ Dysfunction and Failure in Traumatic Hemorrhage
    E.1.1.1Medical condition in easily understood language
    Organ failure following severe injury-induced critical bleeding
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    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 determine whether Artesunate is safe and effective in treating severely-injured patients with traumatic haemorrhage in addition to the current standard management.
    E.2.2Secondary objectives of the trial
    We have discovered that when administered at small doses upon resuscitation, the anti-malarial drug Artesunate reduces multiple organ failure in rodent models of traumatic hemorrhage. We now wish to conduct a Phase 2a clinical trial aimed at testing the safety and effectiveness of Artesunate in patients with trauma and severe haemorrhage.

    In the first phase of the study, we wish to administer Artesunate to patients with trauma-haemorrhage at an identical dose to that used for the treatment of malaria (i.e. low dose; 2.4mg/kg). Although in malaria Artesunate is repeatedly administered every 12 hrs, we propose to inject only one dose. Provided an interim analysis demonstrates no concerns with safety of Artesunate, we will proceed to administer a higher dose of Artesunate (i.e. 4.8 mg/kg) to examine whether the higher dose is more effective in improving outcomes following trauma haemorrhage, whilst still being safe to give to patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible for the study if they meet the following criteria;

    • Adult trauma patients
    • Activation of the local massive haemorrhage protocol
    • Patients with active, ongoing haemorrhage
    E.4Principal exclusion criteria
    The principle exclusion critieria include:

    • Patients not expected to survive >48 hours
    • Patients with evidence of severe traumatic brain injury (GCS 3 at scene)
    • Known pregnancy
    • Suspected non-haemorrhagic cause of shock
    • Massive haemorrhage protocol activation >1 hour after arrival
    • IMP administration not attainable within 4 hours of injury
    • Admission greater than 2 hours post injury
    • Breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    Sequential Organ Failure Score (SOFA) at 48 hours
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours
    E.5.2Secondary end point(s)
    • Maximum SOFA score (Admission to day 7)
    • Prolonged organ failure (SOFA>5 on day 7)
    • Total length of hospital stay (days)
    • Days on organ support (CTCOFR score to discharge, 28-day)
    • Total critical care stay (days)
    • Ventilator free days at Day 28 (days)
    • Incidence of acute lung injury (to discharge, 28-day)
    • Incidence of acute kidney injury (to discharge, 28-day)
    • Incidence of infection (to discharge, 28-day)
    • Mortality (Discharge, 28-day and 90-day)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As indicated above.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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.8.5The 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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The study will be considered to be closed when all surviving participants have completed in-hospital safety and outcomes monitoring (including Mortality at discharge, 28-day and 90-day).
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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 Yes
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-11-30. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adult trauma patients incapacitated as either/both the result of injury or their acute medical care
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 105
    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 are no arrangements for continued provision of the intervention once the research is finished. The investigational medicinal product is given as a single bolus dose upon enrollment in the trial, and no further doses will be dispensed thereafter. The patient will be monitored for 28 days or until discharge.
    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 Decision2016-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-07-21
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