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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-004660-47
    Sponsor's Protocol Code Number:BCX1812-203
    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:2007-10-16
    Trial 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 number2007-004660-47
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate
    the Virologic Activity, Safety, and Pharmacodynamics of Intravenous
    Peramivir for the Treatment of Experimental Influenza
    A.4.1Sponsor's protocol code numberBCX1812-203
    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 SponsorBioCryst Pharmaceuticals 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 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 namePeramivir
    D.3.2Product code BCX-1812
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPeramivir
    D.3.9.1CAS number 330600-85-6
    D.3.9.2Current sponsor codeBCX-1812
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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
    Treatment of experimental influenza
    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 evaluate the virologic activity of peramivir by intravenous
    administration compared to placebo against experimental
    challenge with A/Panama/2007/99.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of peramivir 400 mg
    administered intravenously once daily for five days to healthy
    adults aged 18 to 49 years who are selected based on serologic
    evidence of susceptibility to A/Panama/2007/99.

    To assess the frequency and severity of influenza symptoms in
    subjects receiving either peramivir or placebo following
    experimental challenge with A/Panama/2007/99.

    To assess the time to resolution of fever in subjects receiving
    either peramivir or placebo following experimental challenge
    with A/Panama/2007/99.

    To assess the pharmacodynamic relationship between exposure
    to peramivir (as measured by plasma drug concentrations) and
    virological response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for enrollment if all of the following
    apply:

    1. Male or Female (non-pregnant, non-lactating), age 18 to
    49 years, inclusive.
    2. Comprehension of the study requirements; availability
    for the required study period, ability to attend scheduled
    study visits, and willingness to participate in the inpatient challenge.
    3. Willingness to provide written consent for participation
    after reading the Consent Form and after having
    adequate opportunity to discuss the study with an
    Investigator or qualified deputy.
    4. Good general health status as determined by a screening
    evaluation completed ≤ 42 days prior to challenge.
    5. For female subjects, provision of a history of reliable
    contraceptive practices (hysterectomy or bilateral tubal
    ligation, oral or implanted contraceptive use,
    intrauterine device, barrier method plus spermicide,
    history of a single male partner with vasectomy, or a
    history of sexual abstinence deemed credible by the
    Investigator). Males enrolled must ensure that their female partners of childbearing potential utilize approved contraceptive methods to avoid pregnancy.
    6. Reciprocal serum titer of serum haemagglutinationinhibiting
    (HAI) antibody to A/Panama/2007/99 that is
    ≤ 10.
    E.4Principal exclusion criteria
    Subjects with any of the following will be excluded from
    possible enrolment in the study:
    1. Presence of significant acute or chronic, uncontrolled
    medical or neuropsychiatric illness (subjects with
    uncomplicated chronic conditions or diseases that are
    deemed stable and under satisfactory treatment for ≥
    three (3) months (e.g., mild hypertension well-controlled
    with medication) may be enrolled, provided neither the
    condition and/or the therapy being received are known
    to be associated with an immunocompromised state or
    increased risk of complications of influenza).
    2. Venous access deemed inadequate for the administration
    of intravenous study drug or the phlebotomy
    requirements of the study.
    3. Positive serologic test for HIV infection, or evidence of
    illicit drug use as determined by urine screening.
    4. ALT or AST > 2x the upper limit of normal; serum
    creatinine > 1.6 mg/dL, or any clinical laboratory test
    value deemed by the Investigator to indicate or suggest
    significant undiagnosed acute or chronic illness.
    5. Abnormal ECG at the screening visit demonstrating
    medically significant dysrhythmia and/or suggestive of
    ischemia or myocardial disease.
    6. In female subjects, a positive urine β-HCG during
    screening, or on the day of influenza virus challenge.
    7. During the 4 weeks prior to challenge, daily use for at
    least 14 days of any oral medication or other product
    (prescription or over-the-counter), for symptoms of
    rhinitis or nasal congestion; or chronic use of any
    intranasal medication for any indication.
    8. Any history during adulthood of Asthma or Chronic
    Obstructive Pulmonary Disease (COPD) of any
    etiology; and any history of chronic nasopharyngeal
    disease or complaint (e.g. nasal polyps, chronic rhinitis).
    9. Subjects who are habitual smokers. Occasional smokers
    (defined as ≤ 4 cigarettes/week) who are willing to
    desist for the duration of the inpatient challenge
    component of the study may be eligible.
    10. Acute use of any medication or other product,
    prescription or over-the-counter, for symptoms of
    rhinitis or nasal congestion within seven (7) days prior
    to the first study drug dose.
    11. Any anatomic or neurologic abnormality impairing the
    pharyngeal gag reflex or condition associated with an
    increased risk of aspiration, or a history suggestive of
    such a problem.
    12. Receipt of systemic (oral or injectable) glucocorticoids
    (in a dose ≥ 5 mg prednisone daily or equivalent) within
    one (1) month of challenge, or receipt of any other
    cytotoxic or immunosuppressive drug within six (6)
    months of challenge.
    13. Receipt of any investigational drug within one (1)
    month, or prior participation in any clinical trial
    evaluating treatment or prevention of influenza virus
    infection within six (6) months.
    14. Presence of any febrile illness or symptoms of upper
    respiratory infection (greater than grade 1, “mild”) at a
    time after admission to the CRU and up to the time of
    planned influenza virus challenge (Such subjects may
    be re-evaluated for enrollment after resolution of the
    illness).
    E.5 End points
    E.5.1Primary end point(s)
    The change (reduction) from baseline in influenza virus titer by
    serial measurements of tissue culture infective dose (TCID50).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Yes
    F.3.2Patients No
    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 state51
    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 Decision2007-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-08-28
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