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    Summary
    EudraCT Number:2009-015606-19
    Sponsor's Protocol Code Number:HGT-FIR-054
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-15
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2009-015606-19
    A.3Full title of the trial
    A Phase III Randomized Double-blind, Placebo-controlled Multicenter Study of Icatibant for Subcutaneous Injection in Patients with Acute Attacks of Hereditary Angioedema (HAE)
    A.3.2Name or abbreviated title of the trial where available
    FAST-3
    A.4.1Sponsor's protocol code numberHGT-FIR-054
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJerini US Inc
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Firazyr
    D.2.1.1.2Name of the Marketing Authorisation holderJerini AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/03/133
    D.3 Description of the IMP
    D.3.1Product nameIcatibant
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 138614-30-9
    D.3.9.2Current sponsor codeHGT-FIR-054
    D.3.9.3Other descriptive nameICATIBANT ACETATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hereditary angioedema (HAE) in adults patients with C1-esterase inhibitor deficiency
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10019860
    E.1.2Term Hereditary angioedema
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of icatibant with placebo on the time to symptom relief using a composite Visual Analog Scale (VAS) during moderate to very severe acute cutaneous and/or abdominal attacks in patients with type I or type II hereditary angioedema (HAE)
    E.2.2Secondary objectives of the trial
    a) To compare the efficacy of icatibant with placebo on the time to onset of symptom relief using the VAS score for a single primary symptom

    b) To compare the efficacy of icatibant with placebo on the time to symptom relief using a composite VAS score during moderate to very severe acute cutaneous/abdominal attacks and randomized mild to moderate laryngeal attacks

    c) To compare the global outcome following treatment with icatibant or placebo using patient-reported and physician-reported outcome measures

    d) To compare the time to almost complete symptom relief following treatment with icatibant or placebo during moderate to very severe acute cutaneous and/or abdominal attacks

    e) To assess safety and tolerability of icatibant compared with placebo

    f) To assess the efficacy and safety of icatibant treatment in patients experiencing laryngeal edema attacks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet the following criteria to be enrolled in this study:

    1) The patient is ≥18 years old at the time of informed consent.
    2) The patient has a documented diagnosis of HAE type I or II. The diagnosis will be confirmed either by documented decreased C4 levels and/or immunogenic or functional C1-INH deficiency results (<50% of normal levels) consistent with HAE types I and II or by medical history. Inclusion will be permitted initially based on medical history alone only if a clear diagnosis has been made using all of the following criteria:

    a. Family history
    b. Characteristic attack manifestations, recurrent attacks
    c. Historical functional C1-INH (<50% of normal levels)
    d. Exclusion of other forms of angioedema including acquired angioedema based on normal C1q levels at time of screening.
    e. Subsequent confirmation of the diagnosis is to be made by C1-INH level and function, and C1q and C4 results measured in a central laboratory. If there are any discrepancies between the local laboratory results and medical history, the patient can only be included in the efficacy analysis if diagnosis of HAE has been clearly confirmed clinically and a rationale for the functional level of C1-INH ≥50% of normal can be given; these specific cases are to be discussed with the Sponsor prior to treatment. If there is a discrepancy between C4 and C1-INH levels, the results will be reviewed by the sponsor but C1-INH levels will be used to determine eligibility of the patient.

    3) The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.

    4) Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by investigator global assessment at pretreatment assessments.

    5) The patient must report at least 1 VAS score ≥30mm.

    6) The patient commences treatment within 6 hours of the attack becoming at least mild (laryngeal) or moderate (non-laryngeal) in severity, but not more than 12 hours after the onset of the attack.

    7) The patient must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient.

    8) Women of childbearing potential must have a negative urine pregnancy test and must use appropriate methods to prevent pregnancy during their participation in the study.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from the study:

    1) The patient has a diagnosis of angioedema other than HAE (non-hereditary angioedema, eg, acquired angioedema).

    2) The patient has received previous treatment with icatibant.

    3) The patient has participated in a clinical trial and has received treatment with another investigational medicinal product within the past 30 days.

    4) The patient has received treatment with any pain medication since the onset of the current angioedema attack.

    5) The patient has received replacement therapy (fresh frozen plasma [FFP], C1-INH products) less than 5 days (120 hours) from the onset of the current angioedema attack.

    6) The patient is receiving treatment with angiotensin converting enzyme (ACE) inhibitors.

    7) The patient has evidence of coronary artery disease based on medical history at the Screening examination or at pretreatment; eg, unstable angina pectoris or severe coronary heart disease and congestive heart failure, that in the Investigator’s judgment would be a contraindication for participation in the trial. (New York Heart Association [NYHA] class 3 and 4).

    8) The patient has a serious concomitant illness or condition that, in the opinion of the Investigator, would be a contraindication for participation in the trial.

    9) The patient is pregnant or breastfeeding.

    10) The patient is unable to understand the nature, scope, and possible consequences of the protocol, or is unlikely to comply with the protocol assessments, unable to return for follow up visits, or unlikely to complete the study for any reason.
    E.5 End points
    E.5.1Primary end point(s)
    Time to symptom relief for the first attack (cutaneous and/or abdominal), as assessed by the patient and defined as a 50% reduction from the pretreatment score in the 3-symptom composite VAS
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The double-blind phase of the study is anticipated to take approximately 12 months from the start of treatment of the first patient and will close with the Day 14 assessment for the last patient’s first attack. The study will be closed to enrollment when 88 patients with abdominal and/or cutaneous symptoms have completed the double-blind phase of the study.
    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 months0
    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 months0
    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.1.3Elderly (>=65 years) Yes
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 88
    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 standard of care will be provided
    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 Decision2010-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-12
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