A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver
- Conditions
- Autoimmune Hepatitis (AIH)MedDRA version: 20.1Level: PTClassification code 10003827Term: Autoimmune hepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-001555-32-GB
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
- AIH diagnosed per International Autoimmune Hepatitis Group
- Liver biopsy with Ishak modified HAI indicating active AIH
- Incomplete response to OR intolerance of standard therapy (per AASLD)
Other protocol-defined inclusion criteria may apply
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- Prior use of any B-cell depleting therapy
- Required regular use of medications with known hepatotoxicity
- Decompensated cirrhosis
- Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC)
- Drug related AIH at screening or a history of drug related AIH
- History of drug abuse or unhealthy alcohol use
- History of malignancy of any organ system
- Pregnant or nursing (lactating) women
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the study is 2-fold:<br>Part 1 - To determine effects of different ianalumab doses on ALT normalization at Week 24 in patients with AIH who are incomplete responders (i.e. did not achieve normalization of ALT) or intolerant to standard therapy.<br><br>Part 2 - To confirm the efficacy (biochemical and histological remission) and safety of the dose determined from Part 1 in this population.;Secondary Objective: Part 1 aims to evaluate the dose-response relationship of ianalumab with respect to normalization in ALT at Week 24.<br><br>Other protocol-defined secondary objectives may apply;Primary end point(s): Part 1: ALT normalization;Timepoint(s) of evaluation of this end point: 24 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Part 1: ALT normalization by dose;Timepoint(s) of evaluation of this end point: 24 weeks<br><br>