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    Summary
    EudraCT Number:2009-010798-19
    Sponsor's Protocol Code Number:FE202158CS02
    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:2009-07-28
    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 number2009-010798-19
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, infusion proof-of-concept trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of FE 202158 in patients with vasodilatory hypotension in early septic shock
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of the V1a Agonist FE 202158 in Patients With Septic Shock
    A.4.1Sponsor's protocol code numberFE202158CS02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01000649
    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 SponsorFerring Pharmaceuticals A/S
    B.1.3.4CountryDenmark
    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 supportFerring Pharmaceuticals A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerring Pharmaceuticals
    B.5.2Functional name of contact pointClinical Development Support
    B.5.3 Address:
    B.5.3.1Street AddressKay Fiskers Plads 11
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2300
    B.5.3.4CountryDenmark
    B.5.6E-mailDK0-Disclosure@ferring.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 nameFE 202158 0.1 mg/ml
    D.3.2Product code FE 202158
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 876296-47-8
    D.3.9.2Current sponsor codeFE 202158
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vasodilatory hypotension in early septic shock
    E.1.1.1Medical condition in easily understood language
    Septic shock
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish Proof-of-Concept for specific V1a agonism in patients with vasodilatory hypotension in early septic shock (stabilisation of adequate blood pressure)
    E.2.2Secondary objectives of the trial
    a) To assess the pharmacokinetics of FE 202158 in patients with vasodilatory hypotension in early septic shock
    b) To assess the pharmacodynamic effects of FE 202158 with special focus on blood pressure, vascular leakage and inflammatory response.
    c) To detect early signals suggestive of clinical efficacy of FE 202158 (morbidity and mortality)
    d) To assess the safety and tolerability of FE 202158 in patients with vasodilatory hypotension in early septic shock
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All of the following inclusion criteria must be met before the subject can enter into the trial:

    1. Signed informed consent form by the patient or a legal representative according to local regulations
    2. Man or woman 18 years of age or older
    3. Proven or suspected infection
    4. Vasodilatory hypotension (systolic blood pressure less than 90 mmHg or decrease in systolic blood pressure by at least 40 mmHg for more than one hour) that has not responded to fluid (20 ml/kg of crystalloid or 10 ml/kg of colloid), requiring norepinephrine at a dose of at least 0.1 µg/kg/min, or a minimal dose of 11.5 µg/min (males) and 10.0 µg/min (females) for patients with a body weight above 115 kg (men) or 100 kg (women) for at least 2 hours
    5. Signs of tissue hypoperfusion (at least one of the following criteria): Oliguria (< 0.5 ml/kg/hr for 1 hour), decreased Glasgow Coma Score (< 13) if fully assessable, i.e. only in non-sedated and non-ventilated patients, decreased PaO2/FiO2 ratio (≤ 300 in the presence of other dysfunctional organs or systems than the lung or ≤ 200 if the lung is the only dysfunctional organ), increased arterial blood lactate (≥ 2.5 mmol/L).
    6. Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from informed consent to one week after the end of infusion of study medication.
    E.4Principal exclusion criteria
    Any subject meeting one or more of the following exclusion criteria can not be included in the trial:

    1. Present or a history (within the last 5 years) of acute coronary syndrome (myocardial infarction or unstable angina). Patients who have been asymptomatic for 6 months after coronary revascularisation are eligible. Known or suspected coronary ischemia.
    2. Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test
    3. Known or suspected cardiac failure, e.g. CI < 3 l/min/ m2, left ventricular ejection fraction (LVEF) ≤ 40 %, bilateral pulmonary edema/congestion and cardiomegaly, ScvO2 (superior vena cava) < 64 %, known or suspected coronary ischemia, cold extremities with delayed capillary filling, distended neck veins.
    4. Pregnancy or breastfeeding
    5. Any cause of hypotension other than early septic shock
    6. Use of vasopressin or terlipressin for blood pressure support during the current hospital admission
    7. Proven or suspected acute mesenteric ischemia, as judged by the investigator
    8. Known episode of septic shock within 1 month prior to randomisation
    9. Death anticipated within 24 hours
    10. Underlying chronic heart disease, including heart failure NYHA class III or IV
    11. Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker
    12. Hyponatremia (serum/plasma sodium <130 mmol/L)
    13. Traumatic brain injury (Glasgow Coma Score <8 prior to onset of sepsis)
    14. Present hospitalisation with burn injury
    15. Symptomatic peripheral vascular disease including Raynaud’s syndrome
    16. Previously randomised in this trial
    17. Intake of an IMP within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study)
    18. Known participation in another clinical trial
    19. Considered by the investigator to be unsuitable to participate in the trial for any other reason
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints:

    Stabilisation of blood pressure
    a) Proportion of patients maintaining target MAP with no open label NE at 12 hours, 24 hours, 48 hours, 96 hours and Day 7
    b) Proportion of patients maintaining target MAP at 12 hours, 24 hours, 48 hours, 96 hours and Day 7
    c) Cumulative dose and infusion rates of open label NE (every 12 hours for 3 days, then daily)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 96 hours and Day 7
    E.5.2Secondary end point(s)
    Pharmacokinetics, Pharmacodynamics, Effect on vascular leakage, safety and tolerability, morbidity, mortality
    E.5.2.1Timepoint(s) of evaluation of this end point
    Several - please refer to protocol
    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 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 Yes
    E.8.2.3Other No
    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 EEA8
    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
    Belgium
    Canada
    Denmark
    United States
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 No
    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) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to their medical condition (septic shock) the subjects to be included in the clinical trial will be incapable of giving consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 90
    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 plans for treatment or care after the subject has ended his/her participation in the trial.
    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 Decision2009-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-14
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