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    Summary
    EudraCT Number:2017-001171-23
    Sponsor's Protocol Code Number:ON/2016/6004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-07-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-001171-23
    A.3Full title of the trial
    A multicentre randomised trial of First Line treatment pathways for newly diagnosed Immune Thrombocytopenia: Standard steroid treatment versus combined steroid and mycophenolate.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FLIGHT - A multicentre randomised trial of first line treatment pathways for newly diagnosied immune thrombocytopenia patients.
    A.3.2Name or abbreviated title of the trial where available
    FLIGHT Study, V1.0
    A.4.1Sponsor's protocol code numberON/2016/6004
    A.5.4Other Identifiers
    Name:Clinicaltrials.govNumber:NCT03156452
    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 SponsorUniversity Hospitals Bristol NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationUniversity Hospitals Bristol Foundation NHS Trust
    B.5.2Functional name of contact pointCharlotte Bradbury
    B.5.3 Address:
    B.5.3.1Street AddressBristol Haemophilia Centre, Location D701, Level 7, Horfield Road
    B.5.3.2Town/ cityBristol
    B.5.3.3Post codeBS2 8ED
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number07973353316
    B.5.6E-mailc.bradbury@bristol.ac.uk
    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 Mycophenolate Mofetil
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMycophenolate Mofetil
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMycophenolate mofetil
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immune Thrombocytopenia
    E.1.1.1Medical condition in easily understood language
    An illness that causes bruising and bleeding due to a low platelet count (blood cells essential for normal clotting).
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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 demonstrate which first line treatment pathway helps patients with ITP achieve a stable platelet count sooner, measured as survival free from treatment failure (time from randomisation to treatment failure).

    To assess this question definitively in a fully powered multicentre randomised controlled trial of the two different treatment pathways in patients followed up for a minimum of 12 months from randomisation.
    E.2.2Secondary objectives of the trial
    Collecting data on time to treatment failure as measured objectively by a fall in platelet count to <30x10^9/L and need for new treatment
    Collecting clinical data on additional treatments (including "rescue treatments" such as IVIG (immumoglobulin therapy)
    Collecting clinical data on cumulative steroid dose.
    Collecting clinical data on additional investigations, hospital appointments and admissions
    Collecting patient reported outcomes through standardised questionnaires.
    Collecting resource use data relating to an NHS/PSS and societal perspective.
    Collecting data on treatment side effects and adverse events (including bleeding, infections and steroid side effects)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Flight Extra blood sample collection study.

    Related objectives: To develop laboratory biomarkers to improve the prediction of clinical outcomes in ITP including illness severity, chronicity and response to treatment. The long term aim is to individualise treatment strategy for patients with ITP, enabling earlier disease control and avoiding side effects of ineffective or unnecessary treatments.
    E.3Principal inclusion criteria
    • Patients (males and females) >16 years old with a diagnosis of ITP, a platelet count <30x10^9/L AND a clinical need for first line treatment.
    • Patients have provided written informed consent
    E.4Principal exclusion criteria
    • The exclusion criteria include pregnancy and breastfeeding
    • Patients with HIV, Hepatitis B or C, or Common Variable immunodeficiency.
    • Women of child bearing potential require a pregnancy test result within 7 days prior to randomisation to rule out unintended pregnancy
    • Contraindications to MMF or steroid including patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients or active significant infection
    • Patients not capable of giving informed consent (e.g. due to incapacity)
    • Patients unwilling to follow contraceptive advice if allocated to MMF treatment arm:
    WOMEN: Because of the genotoxic and teratogenic potential of MMF, women of childbearing potential must be willing to use a highly effective method of contraception before and six weeks after stopping MMF (hormonal or barrier method of birth control; abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods.

    NB: Women are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

    MEN: Sexually active men with female partners that are potentially child bearing are recommended to use condoms during treatment and for at least 90 days after cessation of treatment. Condom use applies for both reproductively competent and vasectomised men, because the risks associated with the transfer of seminal fluid also apply to men who have had a vasectomy. In addition, female partners of male patients treated with MMF are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of MMF.
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomisation to treatment failure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Refractory patients (platelet <30x10^9/L in spite of 2 weeks treatment in the steroid arm or platelet <30x10^9/L in spite of 2 months treatment in the steroid +MMF arm) or who initially respond but then relapse (defined clinically as platelet <30x10^9/L and need for further therapy).
    E.5.2Secondary end point(s)
    1. Remission rates (pl >30 x10^9/L and at least 2 fold increase from baseline). Complete >100x10^9/L, partial 30-100x10^9/L
    2. Time to relapse
    3. Time to next therapy
    4. Cumulative steroid dose
    5. Bleeding events
    6. Need for rescue therapies
    7. Need for splenectomy
    8. Time off work
    9. Number of hospital admissions, day unit and clinic attendances
    10. Fatigue
    11. Quality of life
    12. Medication side effects, toxicity or other adverse events (including infection episodes)
    13. NHS costs
    14. Personal and social costs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Hospital monitoring of platelet levels is part of routine care for ITP patients and we will collect these details from the medical notes without requiring patients to come in for additional samples to be taken. These locally collected samples may be collected monthly (or less often) for patients believed to be in stable remission and weekly at lower or declining platelet levels. We expect this to allow us to calculate the time in remission and time in relapse with reasonable accuracy over the 12 month follow up period. In addition to clinical data taken from medical records, we will also ask the patients to complete questionnaires on fatigue, quality of life and bleeding scores at baseline, 2, 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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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.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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned30
    E.8.5The trial involves multiple Member States No
    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
    In order to confirm the treatment failure endpoint has been reached, we will collect the platelet levels details from sites after all their patients have completed the follow up visits at any given site to the end of the trial. Priority data to be collected would be platelet count data (remission, relapse) and treatment data (treatment taken or not taken). There will be no requirement for patients to come in for additional samples/visits, this information would be available from medical notes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 120
    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)
    The aim is to continue on participants on the lowest dose of mycophenolate mofetil that achieves a haemostatic (safe) platelet count (platelet >30x10^9/L) and to ensure that patients who have gone into a spontaneous remission do not continue to take the drug indefinitely.

    If treatment failure occurs further treatment will be chosen by clinician according to individual patient needs.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-12
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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