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    Summary
    EudraCT Number:2007-001107-38
    Sponsor's Protocol Code Number:SESCHI.26371
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-31
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-001107-38
    A.3Full title of the trial
    Dose finding study to investigate efficacy and tolerability of a 6 month oral treatment with selenium in patients with autoimmune thyroiditis:
    prospective, controlled parallel group study with Cefasel versus placebo
    - double blind, randomised clinical multicentre study of phase II with four treatment groups -

    Study title in German (see study protocol):
    Dosisfindungsstudie zur Untersuchung der Wirksamkeit und Verträglichkeit einer 6-monatigen oralen Selen-Behandlung bei autoimmuner Thyreoiditis: prospektiver, kontrollierter Parallelvergleich von Cefasel versus Placebo
    - doppelblinde, randomisierte, klinische Multizenterstudie der Phase II mit vier Behandlungsgruppen -
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose finding study (phase II) to investigate efficacy and tolerability of a 6 month oral treatment with three different strenghts of selenium (trade name: Cefasel) compared to placebo in patients with autoimmune thyroiditis (Hashimoto's disease, inflammation of the thyroid):
    double blind, random allocation to treatment groups
    A.4.1Sponsor's protocol code numberSESCHI.26371
    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 SponsorCefak KG
    B.1.3.4CountryGermany
    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 supportCefak KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNot Applicable
    B.5.2Functional name of contact pointNot Applicable
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post codeNot Applicable
    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 Cefasel 100 µg
    D.2.1.1.2Name of the Marketing Authorisation holderCefak KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 INNSelenium
    D.3.9.1CAS number 7782-49-2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 µg
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autoimmune thyroiditis (Hashimoto-thyroiditis)
    E.1.1.1Medical condition in easily understood language
    Special type of inflammaty disease of the thyroid
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10019167
    E.1.2Term Hashimoto's thyroiditis
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the optimal dose with the best efficacy of a 6 month oral treatment with 100 µg, 200 µg and 300 µg selenium daily compared to placebo concerning the autoimmune process and the function of the thyroid gland in patients with autoimmune thyroiditis.
    E.2.2Secondary objectives of the trial
    The secondary objective is to investigate the tolerability of a 6 month oral treatment with 100 µg, 200 µg and 300 µg selenium daily compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Mature ambulant patient at the age of 18 - 80 years
    2. Patients who have given their signed declaration of consent and data protection declaration
    3. Thyroid peroxidase (TPO) antibody titre at least tenfold above the normal range or at least fivefold above the normal range and positive finding on sonograhy (diffuse reduced echogenicity of the tissue)
    4. Basal TSH < 4.5 mIU/l and FT4 within normal ranges
    E.4Principal exclusion criteria
    1. Previous and concomitant therapy not permitted
    2. Basedow's disease
    3. Further manifestations of pluriglandular insufficiency syndrome with the exception of vitiligo
    4. Indication of thyroid functional autonomies
    5. Manifest hypothyroidism, defined by basal TSH above normal range for the respective method and FT4 below normal range
    6. Previous radioiodine therapy or operation on the thyroid
    7. Suspicion to a malign tumour of the thyroid gland on sonography
    8. Indication of malassimilation
    9. Intolerance against any excipient of Cefasel 100 µg
    10. Females in the childbearing years without appropriate contraception
    11. Pergnancy (present or planned) or lactation
    12. Present malign disease (current or within the past 5 years without recurrence)
    13. Severe somatopahtic, neurological and/or psychiatric diseases
    14. Patients who do not agree to the transmission of their pseudonymous data within the liability of documentation and notification
    15. Participation in another clinical trial (parallel or within the past 6 months)
    16. Participation in the same clinical trial
    17. History of alcohol and/or drug of abuse
    18. Patients who are unable to understand the nature, scope and possible impact of the study or considered to be non-compliant concerning drug intake or the study activities
    19. Planned move or holidays during the course of the study so that not all study visits can be followed
    20. Insufficient knowledge of language (German in written and spoken)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference for the concentration of TPO antibodies after 6 month therapy with selenium relative to baseline for the treatment groups 100 µg, 200 µg and 300 µg compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months of treatment
    E.5.2Secondary end point(s)
    The secondary endpoints are the concentration of TSH, fT3 and fT4 and will be evaluated analogously to the primary endpoint.

    Furthermore all continous variables will be displayed by location parameters (mean, standard deviation, median, minimum, maximum) and confidence intervals.

    For the following parameters the correlation over time elapsed will be calculated:
    · Concentration of selenium in whole blood and TPO-antibodies
    · Concentration of selenium in whole blood and ioduria (as extent of supply with iodine)
    · TPO-antibodies in serum and ioduria
    · Concentration of TPO-antibodies, TSH-, fT3- and fT4 in serum

    The ratio of patients developing during the course of the study a hypothyroidism requiring treatment (TSH > 10 mIU/l and fT4 in normal range or TSH above and fT4 below normal range) will be evaluated per treatment group and compared between groups.

    Categorial endpoints, e.g. quality of life and sonographic results, will be compared between treatment groups by the Chi-Square-test or by appropriate nonparametric tests

    All other documented parameters will displayed (mean, standard deviation, median, minimum, maximum) with suitable methods between treatment groups.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 months 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 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) 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 trial4
    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 concerned20
    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 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
    Last patient last visit
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-03-31. Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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 attending doctor is decides about further care and treatment of the patient after the end of the clinical trial.
    Patients developing hypothyroidism during the course of the study will be substituted with L-thyroxine by the attending doctor and drop out.
    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 Decision2008-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-18
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