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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 22 January 2018
Main ID:  EUCTR2017-003311-19-DE
Date of registration: 18/09/2017
Prospective Registration: Yes
Primary sponsor: University Medical Centre Hamburg-Eppendorf
Public title: Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximab AIH-MAB
Scientific title: Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximab AIH-MAB
Date of first enrolment: 09/01/2018
Target sample size: 12
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003311-19
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Germany
Contacts
Name: CRO   
Address:  Martinistr. 64 20246 Hamburg Germany
Telephone: +49040524719210
Email:
Affiliation:  CTC North
Name: CRO   
Address:  Martinistr. 64 20246 Hamburg Germany
Telephone: +49040524719210
Email:
Affiliation:  CTC North
Key inclusion & exclusion criteria
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 kn


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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.
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Inflectra (Infliximab)
Pharmaceutical Form: Concentrate for solution for infusion

Primary Outcome(s)
Main Objective: 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
Primary end point(s): Biochemical remission of autoimmune hepatitis defined as normalization of AST, ALT and IgG at month 6.
Secondary Objective: Secondary objectives include quality of life during the trial, decreasing liver elastography as a marker for intrahepatic inflammation and the absence of weight gain.
Timepoint(s) of evaluation of this end point: At month 6
Secondary Outcome(s)
Secondary 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
Timepoint(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
Secondary ID(s)
AIH-MAB
Source(s) of Monetary Support
University Medical Centre Hamburg-Eppendorf
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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