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-SE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- 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<br>normalization at Week 24 in patients with AIH who are incomplete<br>responders 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>