Main
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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:
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EUCTR |
Last refreshed on:
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13 July 2020 |
Main ID: |
EUCTR2017-001555-32-SE |
Date of registration:
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02/11/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver
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Scientific title:
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A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER |
Date of first enrolment:
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19/12/2017 |
Target sample size:
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80 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001555-32 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Denmark
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Germany
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Japan
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Netherlands
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Medical information
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Address:
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Box 1218
164 28
Kista
Sweden |
Telephone:
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+46 8 7323200 |
Email:
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medinfo.se@novartis.com |
Affiliation:
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Novartis Sverige AB |
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Name:
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Medical information
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Address:
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Box 1218
164 28
Kista
Sweden |
Telephone:
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+46 8 7323200 |
Email:
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medinfo.se@novartis.com |
Affiliation:
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Novartis Sverige AB |
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Key inclusion & exclusion criteria
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Inclusion criteria: - 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
Exclusion criteria: - 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Autoimmune Hepatitis (AIH) MedDRA version: 20.1
Level: PT
Classification code 10003827
Term: Autoimmune hepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
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Intervention(s)
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Product Name: ianalumab Product Code: VAY736 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: ianalumab CAS Number: Not establis Current Sponsor code: VAY736 Other descriptive name: anti-BAFFR antibody Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Primary end point(s): Part 1: ALT normalization
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Timepoint(s) of evaluation of this end point: 24 weeks
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Main Objective: The purpose of the study is 2-fold: Part 1- To determine effects of different ianalumab doses on ALT normalization at Week 24 in patients with AIH who are incomplete responders or intolerant to standard therapy.
Part 2 - To confirm the efficacy (biochemical and histological remission) and safety of the dose determined from Part 1 in this population.
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Secondary Objective: Part 1 aims to evaluate the dose-response relationship of ianalumab with respect to normalization in ALT at Week 24.
Other protocol-defined secondary objectives may apply
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 24 weeks
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Secondary end point(s): Part 1: ALT normalization by dose
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Secondary ID(s)
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2017-001555-32-ES
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NCT03217422
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CVAY736B2201
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Source(s) of Monetary Support
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Novartis Pharma AG
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Ethics review
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Status: Approved
Approval date: 18/12/2017
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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