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    EudraCT Number:2011-006094-26
    Sponsor's Protocol Code Number:CTP_STX005/STX005EXT
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-02-10
    Trial results
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    A. Protocol Information
    A.2EudraCT number2011-006094-26
    A.3Full title of the trial
    A Phase II Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 (caStx1) and 2 (caStx2) Administered Concomitantly to Children with Shiga Toxin-Producing Bacterial (STPB) Infection and Bloody Diarrhea (SHIGATEC trial).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study of Antibodies to Shiga Toxins 1 and 2
    A.4.1Sponsor's protocol code numberCTP_STX005/STX005EXT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01252199
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/308/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThallion Pharmaceuticals Inc
    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 supportThallion Pharmaceuticals Inc
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThallion Pharmaceuticals Inc
    B.5.2Functional name of contact pointDidier Reymond, MD
    B.5.3 Address:
    B.5.3.1Street Address1375 Transcanada Highway, Suite 200
    B.5.3.2Town/ cityDorval, Québec
    B.5.3.3Post codeH9P 2W8
    B.5.4Telephone number+1 5142283631
    B.5.5Fax number+15142283622
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/301
    D.3 Description of the IMP
    D.3.1Product nameChimeric monoclonal antibodies to shiga-toxin 1 and 2
    D.3.2Product code caStx1/caStx2
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1351470-16-0
    D.3.9.3Other descriptive namecaStx1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1351470-17-1
    D.3.9.3Other descriptive namecaStx2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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.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 injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Shiga toxin-mediated complications resulting from Shiga toxin producing bacterial infections.
    E.1.1.1Medical condition in easily understood language
    Infection caused by bacteria producing Shiga toxins
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019515
    E.1.2Term Hemolytic uremic syndrome
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety and tolerability of two different intravenous dose levels of a combined caStx1/caStx2 preparation in separate groups of children presenting with STPB infection
    E.2.2Secondary objectives of the trial
    To assess efficacy by examining for each patient a composite endpoint defined as either of the following events:
    1. Presence of macroscopic bloody diarrhea more than 48 hours post-treatment, or
    2. Presence of at least 2 out of 3 criteria of HUS defined as: a/ serum creatinine > ULN adjusted for age and gender, b/ platelets < 150 x 10^3/µL, and c/ hemolytic anemia (hematocrit < 30% with evidence of hemolysis (as indicated by LDH above the upper limit of normal age or the finding of schistocytes on peripheral smear in an anemic child).

    To evaluate the PK characteristics of caStx1 and caStx2
    To assess the frequency of induction of human anti-chimeric antibodies (HACA)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Extension study (STX005EXT)

    To assess at 6 and 12 months the incidence of long term kidney injury: 1/ arterial hypertension; 2/ chronic renal insufficiency; 3/ end-stage renal failure between groups.

    To assess at 6 and 12 months the long-term presence of HACA and incidence of potential treatment-induced immune-complex diseases.
    E.3Principal inclusion criteria
    1. Written, signed and dated informed consent by a parent or legally acceptable representative and age appropriate patient assent
    2. Age between 6 months and 18 years (inclusively)
    3. Bloody diarrhea (by visual inspection) for no more than 36 hours prior to screening.
    4. Females of child-bearing potential and sexually active must have negative urine pregnancy test prior to administration of study medication. Abstain from sexual activity or use of acceptable contraceptive measures.
    5. Detection of Shiga toxin (Stx1 and/or Stx2) in stool by a rapid diagnostic test (Meridian Premier EHEC Assay) or antigens from Shiga toxin producing E Coli 0157 by the ImmunoCard STAT E coli 0157 Plus test
    E.4Principal exclusion criteria
    1. Laboratory findings compatible with development of at least two out of the three following criteria that define HUS: hemolytic anemia, thrombocytopenia and nephropathy
    2. Bloody-diarrhea suspected not to be caused by STPB but by other organisms or preexisting diseases
    3. History of renal disease or malformation. Active renal disease including infection, and isolated macrohematuria
    4. Family history of proven or suspected hereditary HUS or TTP
    5. Clinically significant and/or uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophtalmologic, immunologic or other significant disease
    6. History of chronic/recurrent hemolytic anemia or thrombocytopenia
    7. Ongoing treatment for malignancy
    8. History of chronic inflammatory bowel disease
    9. Prior treatment with murine, chimeric, or humanized antibody
    10. Breastfeeding women
    E.5 End points
    E.5.1Primary end point(s)
    Safety parameters will include the occurence of AEs and clinical and biological indicators such as vital signs, body weight, physical exam, ECGs, laboratory parameters by age groups: 6 months - 23 months, 2-11 years, 12-18 years
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, 2, 3, 4, 6, 8, 15, 22, 29 and 57 for the core study
    Month 6 and 12 for the extension study
    E.5.2Secondary end point(s)
    Composite endpoint (see E.2.2)
    Incidence of (isolated) serum creatinine
    Incidence of (isolated) hemolytic anemia
    Incidence and duration of (isolated) thrombocytopenia
    Incidence of complete HUS (3 out of 3 criteria)
    Isolated presence of (macroscopic) bloody diarrhea more than 48h post treatment
    Isolated presence of at least 2 out of 3 crietria for HUS
    Incidence and duration of hospitalization
    Incidence and duration of dialysis
    Incidence of seizures
    Incidence and number of red blood cell transfusions
    Treatment effect of the antibodies according to the time elapsed from the first bloody diarrhea episode to treatment (end of infusion)
    Incidence of long term kidney injury
    Incidence of deaths
    Development of HACA per age groups
    PK characteristics of caStx1 and caStx2 by age groups
    Complement levels by age groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    Incidence of long-term kidney injury: 6 and 12 months
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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. 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 Yes
    E. trial design description
    The extension part of the study (STX005EXT) will be open-label
    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 trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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
    LVLS extension study (STX005EXT)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F. of subjects for this age range: 25
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 2
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 42
    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)
    No plan for treatment or care after the subject has ended the participation in the trial is planned
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Argentina
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