Autoimmune Hepatitis (AIH)
Conditions
Interventions
Trade Name: Inflectra (Infliximab)
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
University Medical Centre Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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.;Primary end point(s): Biochemical remission of autoimmune hepatitis defined as normalization of AST, ALT and IgG at month 6.;Timepoint(s) of evaluation of this end point: At month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactCRO
CTC North
Outcome results
None listed