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    EudraCT Number:2017-003311-19
    Sponsor's Protocol Code Number:AIH-MAB
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-18
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2017-003311-19
    A.3Full title of the trial
    Phase IIa proof-of-principle study for the
    induction treatment of autoimmune hepatitis using infliximab
    Phase IIa proof-of-principle Studie zur Wirksamkeit von Infliximab in der Induktionstherapie der Autoimmunen Hepatitis

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIa proof-of-principle study for the
    induction treatment of autoimmune hepatitis using infliximab
    Phase IIa proof-of-principle Studie zur Wirksamkeit von Infliximab in der Induktionstherapie der Autoimmunen Hepatitis

    A.4.1Sponsor's protocol code numberAIH-MAB
    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 Medical Centre Hamburg-Eppendorf
    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 supportUniversity Medical Centre Hamburg-Eppendorf
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTC North
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressMartinistr. 64
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.4Telephone number+49040524719210
    B.5.5Fax number+49040524719129
    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. name Inflectra (Infliximab)
    D. of the Marketing Authorisation holderHospira 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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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 (AIH); rare inflammatory liver disease associated with elevated transaminases, elevated Immunoglobulin G, the presence of autoantibodies and interface hepatitis in liver histology. Untreated, AIH progresses to liver fibrosis and cirrhosis with its complications. Historical placebo-controlled studies could show a mortality of around 70% in the placebo-treated group.

    Die Autoimmune Hepatitis ist eine chronische Entzündung der Leber, die durch eine Reaktion des Immunsystems gegen körpereigenes Lebergewebe ausgelöst wird. Die Ursachen hierfür sind bisher unklar. Die Behandlung der autoimmunen Hepatitis besteht in der Therapie mit sogenannten Immunsuppressiva, also Medikamenten, die das körpereigene Immunsystem schwächen und so die Reaktion gegen das körpereigene Lebergewebe unterdrücken.
    E.1.1.1Medical condition in easily understood language
    Autoimmune Hepatitis (AIH) is rare inflammatory liver disease caused by unknown triggers. Untreated, AIH progresses to to liver fibrosis and cirrhosis with its complications
    Die Autoimmune Hepatitis ist eine chronische Entzündung der Leber, die durch eine Reaktion des Immunsystems gegen körpereigenes Lebergewebe ausgelöst wird. Die Ursachen hierfür sind bisher unklar.
    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
    Steroid treatment is often wearing and may reduce treatment adherence due to multiple side effects. Currently, there is no alternative treatment available for induction treatment of AIH. There are small case series using cyclophosphamide or intravenous cyclosporine A as an induction treatment, but due to toxic side effects, this only serves as an emergency treatment. The rationale of this trial is to show the efficacy of infliximab in the induction treatment for AIH. The primary objective of the AIH-MAB trial is to show that infliximab induces biochemical remission in treatment-naïve patients with auto-immune hepatitis
    E.2.2Secondary objectives of the trial
    Secondary objectives include quality of life during the trial, decreasing liver elastography as a marker for intrahepatic inflammation and the absence of weight gain.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion criteria:
    1. Patients with untreated autoimmune hepatitis diagnosed in ac-cordance to the „simplified criteria for the diagnosis of auto-immune hepatitis“
    2. Female patients: Female subjects must be postmenopausal, surgically sterile, of if premenopausal and not surgically ster-ile, be prepared to use  1 effective method of contraception during the study and for 6 months after the end of treatment visit*.
    3. Must provide written informed consent and agree to comply with the study protocol
    E.4Principal exclusion criteria
    1. Age younger than 18 years old or older than 65 years
    2. Patients with known hypersensitivity to any constituent of the product
    3. History of severe heart disease or heart failure. NYHA class III or IV, severe uncontrolled cardiac disease (unstable angina, ar-rhythmias, clinical significant electrocardiogram abnormalities) or myocardial infarction within 6 months prior to randiomization
    4. Patients with a recent exposure to persons with active tubercu-losis, patients with a positive result in a screening test for la-tent TB (Quantiferon Test) as well as patients with a history of tuberculosis or active tuberculosis
    5. Patients with a current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodefi-ciency virus (HIV) -1 or -2 or who has a positive result in the screening test for those infections; patients who have an acute infection requiring oral antibiotics within 2 weeks before ran-domization, other serious infection within 6 months before randomization or a history of recurrent herpes zoster or other chronic or recurrent infection within 6 weeks before randomiza-tion; patients with a history of tuberculosis or a current diag-nosis of tuberculosis or other granulomatous infections or other severe or chronic infection (such as sepsis, abscess or opportunistic infection, or invasive fungal infection such as histoplasmosis) or a past diagnosis without sufficient docu-mentation of complete resolution following treatment.
    6. Additional liver disease other than autoimmune hepatitis (in-cluding, but not limited to alcoholic liver disease, viral hepati-tis, primary sclerosing cholangitis, primary biliary cholangitis, non-alcoholic steatohepatitis), history of alcohol abuse
    7. History of decompensation of cirrhosis (ascites, variceal bleeding, encephalopathy)
    8. Known or suspected hepatocellular carcinoma, history of any malignancy within 5 years prior to randomization except com-pletely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or cutaneous squa-mous cell carcinoma, history of lymphoma or lymphoprolifera-tive disease or bone marrow hyperplasia
    9. Presence of transjugular intrahepatic portosystemic shunt pro-cedure
    10. Hepatorenal syndrome or creatinine >2mg/dl at screening
    11. Subjects that have undergone bariatric surgery
    12. Female patients who are currently pregnant, breatfeeding or planning to become pregnant or breastfeed within 6 months of the last dose of study drug
    13. Any uncontrolled clinically significant respiratory disease (in the opinion of the investigator) including but not limited to chronic obstructive pulmonary disease, asthma, bronchiecta-sis or pleural effusions
    14. Uncontrolled hypertension (as defined by systolic blood pres-sure ≥160 mmHg or diagstolic blood pressure ≥100 mm Hg)
    15. Diabetes mellitus unless on a stable dosing regimen for at least 4 weeks prior to screening
    16. Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillain Barre syn-drome
    17. Any conditions significantly affecting the nervous sytem (i. e. neuropathic conditions or nervous system damage)
    18. Any other serious or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that may interfere with the interpretation of study results
    19. Other medical conditions that may diminish life expecgancy, including known cancers
    20. Participation in another investigational product, biologic or medical device study within 30 days or 5 half-lives, whichever is longer prior to screening
    21. Mental instability and lack of capabability of giving consent.
    22. History of known or suspected clinically significant hypersen-sitivity to azathioprine or bone marrow disease
    23. History of the use of infliximab
    24. Liver failure (INR > 1,5)
    25. Body weight < 40kg or above 90kg, BMI < 18kg/m2 or > 30kg/m2
    26. Patients not willing or able to comply with the study proce-dures
    27. Transaminase elevation > 1000 U/l
    28. Application of life vaccines 4 weeks prior to treatment or planned application of life vaccines during the treatment
    E.5 End points
    E.5.1Primary end point(s)
    Biochemical remission of autoimmune hepatitis defined as normalization of AST, ALT and IgG at month 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At month 6
    E.5.2Secondary end point(s)
    Stable Quality of life (using standardized tools including the GAD-7, PHQ-9 and SF-12) at week 0, 4, 12, 24 and 48.
    Decrease in Elastography
    Absence of weight gain
    E.5.2.1Timepoint(s) of evaluation of this end point
    at week 0, 4, 12, 24 and 48/End of study
    at Screening, Week 12, 36, 48/End of Study
    each week until EOS
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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. 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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) No
    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 state12
    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)
    Patients will be maintained on remission-preserving treatment according to guidelines.
    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 Decision2018-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
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