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    Summary
    EudraCT Number:2017-003272-31
    Sponsor's Protocol Code Number:NL.EPITRAC.0107.17
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003272-31
    A.3Full title of the trial
    Efficacy and safety of oral itraconazole in the reduction of epistaxis severity in hereditary hemorrhagic telangiectasia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Itraconazole as treatment for severe nose bleeding in patients with hereditary hemorrhagic telangiectasia
    Itraconazol als behandeling voor ernstige neusbloedingen bij patiënten met de ziekte van Rendu-Osler-Weber
    A.3.2Name or abbreviated title of the trial where available
    Itraconazole for epistaxis in HHT patients
    A.4.1Sponsor's protocol code numberNL.EPITRAC.0107.17
    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 SponsorSt. Antonius Ziekenhuis
    B.1.3.4CountryNetherlands
    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 supportZonMw TopZorg
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportStichting Wetenschappelijk Onderzoek Rendu Osler (SWORO)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt. Antonius Ziekenhuis
    B.5.2Functional name of contact pointCentral study coordinator
    B.5.3 Address:
    B.5.3.1Street AddressKoekoekslaan 1
    B.5.3.2Town/ cityNieuwegein
    B.5.3.3Post code3435CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031883201579
    B.5.5Fax number0031883201449
    B.5.6E-mails.kroon@antoniusziekenhuis.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Sporanox
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Farmacêutica Portugal, Lda., Barcarena, Portugal
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameItraconazole
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe epistaxis in patients with Hereditary Hemorrhagic Telangiectasia also known as Rendu-Osler-Weber disease
    E.1.1.1Medical condition in easily understood language
    Severe nose bleedings in patients with Hereditary hemorrhagic telangiectasia also known as Rendu-Osler-Weber disease
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031132
    E.1.2Term Osler-Weber-Rendu disease
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038554
    E.1.2Term Rendu-Osler-Weber syndrome
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study hypothesis: The primary study hypothesis states that oral treatment with itraconazole will reduce the epistaxis severity and frequency due to the anti-angiogenic effects of itraconazole. Study objective: To assess the efficacy and safety of oral itraconazole in HHT patients with severe epistaxis
    E.2.2Secondary objectives of the trial
    Difference in monthly epistaxis duration and frequency after treatment compared to baseline.
    Difference in the mean hemoglobin (Hb) and ferritin levels in HHT patients with epistaxis after treatment compared to baseline.
    Difference in quality of life in HHT patients with epistaxis following treatment after treatment compared to baseline.
    Effects of itraconazole on other HHT associated symptoms such as gastro-intestinal blood loss and presence of telangiectasias after treatment compared to baseline.
    Safety, side-effects and (serious) adverse events of oral itraconazole in HHT patients with epistaxis.
    Long term efficacy of treatment at 1 and 3 months after itraconazole treatment has ended on the severity of epistaxis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with HHT: Definite HHT according to the Curacao criteria (3 positive criteria or more) AND/OR genetically confirmed HHT
    2. Suffering from epistaxis at least on average of 4 days per week;
    3. In the last six months suffering from anemia or iron deficiency or in last twelve months use iron treatment or blood transfusions;
    4. Failure or partial failure of local treatment with systemic treatment indicated by ENT specialist;
    5. Adult (18 years or older at time of inclusion).
    E.4Principal exclusion criteria
    1. Patients with any history of ventricular cardiac dysfunction;
    2. Patients with elevated liver enzymes or any pre-existing liver disease or a history with known liver toxicity caused by medication;
    3. Hypersensitivity or allergy for azole antifungal drugs;
    4. Patients with a severe disease with a life-expectancy <1 year;
    5. Women that are pregnant, nursing, have a pregnancy wish in the study period or who use anticonception inadequately;
    6. Patients currently receiving chemotherapy;
    7. Patients receiving drugs that are metabolized by CYP3A: that prolongate QT-interval (mizolastine, pimozide, sertindole of quinidine), orally administered midazolam, statins (simvastatin, atorvastatin), alkaloids (ergotamine), eletriptan, or drugs that induce CYP3A4 (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital or St John's wort (Hypericum perforatum));
    8. Patients who do not understand English or Dutch language sufficiently enough;
    9. Patients who refuse informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point used in this study is the epistaxis severity score (ESS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End point will be evaluated after 16 weeks of treatment
    E.5.2Secondary end point(s)
    The secondary end points in this study are safety of therapy, the frequency and number of monthly epistaxis measured with an epistaxis diary, hemoglobin levels, ferritin levels, and the quality of life measured with the Short-Form Questionnaire 36 (SF-36).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End point will be evaluated after 16 weeks of treatment
    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 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 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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    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.8.5The 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
    The end of the study is defined as the last patient’s last visit. In case the study is ended prematurely, the sponsor will notify the accredited METC and the competent authority within 15 days, including the reasons for the premature termination. Within one year after the end of the study, the investigator/sponsor will submit a final study report with the results of the study, including any publications/abstracts of the study, to the accredited METC and the Competent Authority.
    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 days
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state25
    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)
    After the trial patients will receive standard care as normal. Since we want evaluate the efficacy and long-term efficacy of itraconazole (after treatment has ended) patients are not allowed to continue taking itraconazole. If the therapy is effective and the patient would like to be retreated with itraconazole this is possible in in consultation with his or her treating physician and the study coordinating or principal investigator(s) after the three months of follow-up.
    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 Decision2018-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-18
    P. End of Trial
    P.End of Trial StatusOngoing
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