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    Summary
    EudraCT Number:2014-000899-25
    Sponsor's Protocol Code Number:FP1CLI006
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-01-11
    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 ConcernedEstonia - SAM
    A.2EudraCT number2014-000899-25
    A.3Full title of the trial
    A Phase II Double-blind, Randomised, Parallel Group 2:1 Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human Interferon Beta-1a) and Placebo in the Prevention of Multi-Organ Failure on Patients Surviving Open Surgery for a Ruptured Abdominal Aortic Aneurysm
    Hulgiorganpuudulikkuse ennetamine ja suremuse vähendamine beeta-1a-interferooniga pärast operatsiooni kõhuaordi aneurüsmi rebendi tõttu

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess effectiveness and safety of a drug FP-1201-lyo (recombinant human interferon beta-1a) in the Prevention of Multi-Organ Failure on patients after Open Surgery for a Ruptured Abdominal Aortic Aneurysm
    Hulgiorganpuudulikkuse ennetamine ja suremuse vähendamine beeta-1a-interferooniga pärast operatsiooni kõhuaordi aneurüsmi rebendi tõttu

    A.3.2Name or abbreviated title of the trial where available
    INFORAAA study
    A.4.1Sponsor's protocol code numberFP1CLI006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03119701
    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 SponsorFaron Pharmaceuticals Ltd
    B.1.3.4CountryFinland
    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 supportFaron Pharmaceuticals Ltd
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFaron Pharmaceuticals Ltd
    B.5.2Functional name of contact pointCMO, VP Drug Development
    B.5.3 Address:
    B.5.3.1Street AddressJoukahaisenkatu 6
    B.5.3.2Town/ cityTurku
    B.5.3.3Post codeFI-20520
    B.5.3.4CountryFinland
    B.5.4Telephone number+35840 149 5277
    B.5.6E-mailmatti.karvonen@faron.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 nameTraumakine
    D.3.2Product code FP-1201-lyo
    D.3.4Pharmaceutical form Lyophilisate for 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.3.8INN - Proposed INNInterferon beta-1a
    D.3.9.1CAS number 145258-61-3
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.2
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typePre-filled syringe containing 1.0 ml water for injection for reconstitue lyophilised IMP.
    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 placeboLyophilisate for solution 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 Multi-Organ Failure on Patients Surviving Open Surgery for a Ruptured Abdominal Aortic Aneurysm.
    E.1.1.1Medical condition in easily understood language
    Post-surgical preventive treatment of patients after emergency surgery for a ruptured abdominal aortic aneurysm.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036654
    E.1.2Term Prevention
    E.1.2System Organ Class 100000022817
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002885
    E.1.2Term Aortic aneurysm repair
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002886
    E.1.2Term Aortic aneurysm rupture
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028154
    E.1.2Term Multi-organ failure
    E.1.2System Organ Class 100000167648
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of FP-1201-lyo over placebo on all-cause mortality at study day 30; D30 .
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of FP-1201-lyo treatment by assessing short term outcomes (D30) and midterm outcomes (D90 [3 months])
    2. To evaluate the safety and tolerability of FP-1201-lyo treatment
    3. To evaluate the pharmacodynamics (PD) of FP-1201-lyo
    4. To evaluate the Tentative Disease Specific Marker CD73 and Potential Inflammatory Markers (PIM)
    5. To evaluate neutralizing antibodies against IFN beta-1a (NAbs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion into this study, each patient must fulfil the following inclusion criteria during screening and prior to the first dose of study medication being administered on D0 (criteria 1 or 2 and all 3, 4 and 5):
    1. Patients (male or female) presenting with a ruptured abdominal aortic aneurysm (RAAA) diagnosed by ultrasound or CT-scan in the emergency room
    • all forms of infrarenal RAAAs with or without coexisting iliac aneurysms are included
    or
    2. Patients (male or female) presenting with symptoms of RAAA known to have an infrarenal AAA and proceeding straight to open repair without radiological assessment and confirmed rupture (=retroperitoneal haematoma) in operation
    and
    3. Aneurysma repair must be infra-renal, i.e. the proximal anastomosis must be below the renal arteries and the renal arteries have to stay intact. Temporary above the renal clamping can be used for a maximum of 30 minutes (total clamping time)
    and
    4. Patients or next of kin providing informed consent
    and
    5. Age of 18 years or higher
    E.4Principal exclusion criteria
    To be eligible for inclusion into this study, each patient must not meet any of the following exclusion criteria during screening or prior to the first dose of study medication being administered:
    1. Moribund patient not eligible for treatment in ICU or expected to survive surgery
    2. Markedly short life expectancy, e.g. advanced malignant disease
    3. Current participation in another experimental treatment protocol
    4. Significant congestive heart failure, defined as New York Heart Association (NYHA) class IV
    5. Current treatment with IFN alpha or IFN beta
    6. Dialysis therapy for chronic renal failure
    7. Irreversible shock from haemorrhage
    8. Unconsciousness when arriving to the hospital and during screening
    9. rEVAR first (prior attempt for endovascular aortic repair for the current rupture)
    10. Diagnosed cirrhosis
    11. Pregnancy and women with child bearing potential without negative pregnancy test
    12. Rupture not confirmed by CT or intra-operatively (impending ruptures are excluded)
    13. RAAA requiring repair of the renal arteries or the proximal aorta
    • thoracoabdominal aneurysms requiring immediate repair
    • damaged renal arteries during emergency clamping requiring repair
    NOTE:
    • temporary clamping above the renal arteries (max 30 min total clamping time above the renal arteries) does not lead to exclusion
    • ligation of the left renal vein does not lead to exclusion
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    • All cause mortality at D30
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • All cause mortality at D90 (3 months)
    • Number of ventilator free days (VFDs) at D30
    • Number of days receiving haemodialysis at D30 and D90
    • Number of organ failure free days up to D30 by means of the SOFA score
    • Prevalence of abdominal compartment syndrome, i.e. intra-abdominal pressure (IAP) between study groups
    • Neutralizing antibodies against IFN beta-1a (NAbs) in whole blood samples up to D30
    • Disability on D90 measured by modified ranking scale (mRS)

    Safety:
    • Clinically significant treatment emergent adverse events (TEAEs) up to D30 from vital signs data, laboratory data, physical examinations and spontaneous reporting when conscious

    Pharmacoeconomics:
    • Length of ICU stay, in terms of ICU free days at D30
    • Length of hospital stay, in terms of hospital free days at D90
    • Length of stay at another health care facility at D90
    • Length of haemodialysis needed
    • Ventilation free days at D30

    Pharmacodynamics (PD):
    • MxA (protein) concentration in whole blood samples from baseline up to D13

    Tentative Disease Specific Marker:
    • CD73 concentration in serum samples from baseline up to D13
    • Potential Inflammatory Markers (IL-6 and HGF) in serum samples from baseline up to D13
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 0-13, Day 30, Day 90
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tentative disease specific markers
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 137
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 152
    F.4.2.2In the whole clinical trial 152
    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)
    None. According to normal practice.
    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 Decision2017-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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