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    Summary
    EudraCT Number:2018-003381-14
    Sponsor's Protocol Code Number:AIHBUDPRED1.0
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2018-003381-14
    A.3Full title of the trial
    Budesonide versus Prednisolone as Primary Treatment for Autoimmune
    Hepatitis: An Open-label, Randomized, Prospective Multicenter 12-month
    Clinical Trial Evaluating Effect and Side-Effects.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Budesonide compared to prednisolone for the treatment of autoimmune
    hepatitis - A prospective randomized multicenter study
    Budesonid jämfört med prednisolon vid behandling av autoimmun hepatit -
    En prospektiv, randomiserad multicenterstudie
    A.3.2Name or abbreviated title of the trial where available
    AIHBUDPRED
    A.4.1Sponsor's protocol code numberAIHBUDPRED1.0
    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 SponsorUmeå University Hospital
    B.1.3.4CountrySweden
    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 supportRegional research councils (ALF)
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska Academy
    B.5.2Functional name of contact pointHanns-Ulrich Marschall
    B.5.3 Address:
    B.5.3.1Street AddressBlå Stråket 5
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code41345
    B.5.3.4CountrySweden
    B.5.4Telephone number46708774073
    B.5.5Fax number463182745
    B.5.6E-mailhanns-ulrich.marschall@gu.se
    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 Prednisolon
    D.2.1.1.2Name of the Marketing Authorisation holderVarious
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 namePrednisolon
    D.3.4Pharmaceutical form Tablet
    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.IMP: 2
    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 Budesonid
    D.2.1.1.2Name of the Marketing Authorisation holderVarious
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameVarious
    D.3.4Pharmaceutical form Capsule, hard
    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
    Autoimmune hepatitis
    E.1.1.1Medical condition in easily understood language
    Autoimmune hepatitis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess differences in treatment effects between budesonide and
    prednisolone in non-cirrhotic newly diagnosed AIH patients with respect
    to time to remission and percentage of patients reaching complete and
    incomplete remission, and number of flares.
    E.2.2Secondary objectives of the trial
    To assess
    (i) the side effects of budesonide (BUD) vs prednisolone (PRED)
    regarding diabetes
    (ii) the side effects of BD vs PRED regarding osteoporosis (change at 1
    year from baseline)
    (iii) the side effects of BUD vs PRED on body weight at week 26 and 52
    (iv) the side effects of BUD vs PRED on the skin at week 26 and 52
    (presence of striae, moon face, hirsutism at week 26 and 52)
    (v) the side effects of BUD vs PRED on QoL (SF36, SHS and WPAI-GH at
    baseline, week 4 and week 52)
    (vi) the effects of BUD vs PRED on liver biopsy (changes in scores from
    baseline to week 52)
    (vii) the effects of BUD vs PREDe on Fibroscan scores at week 13, 26 and
    52.
    (viii) the effects of BUD vs PRED on inflammatory markers such as TNF,
    IL6 and genetic markers on inflammation at week 52 compared with
    baseline.
    (ix) the effects of BUD vs PRED on laboratory markers, such as ASAT,
    ALAT, GT, ALP, Bilirubin and IgG.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A written informed consent is signed before any study-related
    procedures are performed.
    2. Male and female subjects aged ≥18 years of age.
    3. A definitive diagnosis of autoimmune hepatitis with a score of ≥6
    according to the "simplified AIH criteria".
    4. A liver biopsy should, a) have been performed within the last 6
    months, and, b) show interface inflammation grade of ≥1 according to
    the Ludwig-Batts grading scale.
    E.4Principal exclusion criteria
    1. Chronic liver disease other than AIH (PBC, PSC, viral hepatitis,
    hemochromatosis, homozygous alpha-1-antitrypsin deficiency and
    Wilson disease)
    2. Ongoing immune-modulating therapy
    3. Liver cirrhosis/fibrosis grade 4 according to Ludwig-Batts grading
    scale and/or clinically compensated or decompensated liver cirrhosis
    (signs of portal hypertension and/or cirrhosis on radiology, ultrasound
    or MRI).
    4. Current malignancy
    5. Alcohol overconsumption (B-PEth >0.3 μmol/L)
    6. Contraindication to corticosteroids
    7. Contraindication to azathioprine
    8. Suggested non-compliance with the protocol.
    9. Pregnancy or breast-feeding
    E.5 End points
    E.5.1Primary end point(s)
    Complete laboratory remission of AIH (defined as normalized ALAT,
    ASAT and IgG) in each group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One year
    E.5.2Secondary end point(s)
    - Time to complete remission
    - Frequency of partial remission (ALAT and/or ASAT reduced to 1-2x
    ULN)
    - Time to partial remission
    - Frequency of non-responders
    - Frequency of relapsing AIH/flares (increased ALAT from normal to >3
    ULN)
    - Differences in QoL-scores from baseline to week 4 and 52
    - Differences in Fibroscan scores from baseline to week 13, 26 and 52
    - Differences in densitometry-scores from baseline to week 52
    - Differences in Batts & Ludwig scores from baseline to week 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    One year
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) 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 concerned6
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days30
    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: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 2019-12-11. 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 state150
    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)
    Continous therapy with either prednisolone or budesonide that are both recommended first-line therapies of AIH
    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 Decision2020-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-19
    P. End of Trial
    P.End of Trial StatusOngoing
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