95. 自己免疫性肝炎 Autoimmune hepatitis Clinical trials / Disease details


臨床試験数 : 52 薬物数 : 68 - (DrugBank : 27) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111

  
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1EUCTR2017-001555-32-DK
(EUCTR)
08/06/201808/06/2018A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 Autoimmune Hepatitis (AIH)
MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: anti-BAFFR antibody
Novartis Pharma AGNULLNot Recruiting Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden
2EUCTR2017-001555-32-NL
(EUCTR)
26/04/201818/10/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 Autoimmune Hepatitis (AIH)
MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: anti-BAFFR antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Japan;Sweden
3EUCTR2017-001555-32-BE
(EUCTR)
19/03/201818/12/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 Autoimmune Hepatitis (AIH)
MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: anti-BAFFR antibody
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
65Phase 2;Phase 3Argentina;Singapore;United States;Czechia;Japan;United Kingdom;Switzerland;Spain;Canada;Sweden;Czech Republic;Belgium;Denmark;Germany
4NCT03217422
(ClinicalTrials.gov)
February 15, 201812/7/2017ADCC Mediated B-Cell dEpletion and BAFF-R BlockadeA Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune HepatitisAutoimmune HepatitisBiological: VAY736;Other: PlaceboNovartis PharmaceuticalsNULLRecruiting18 Years75 YearsAll65Phase 2/Phase 3United States;Argentina;Belgium;Canada;Czechia;Denmark;Germany;Japan;Netherlands;Singapore;Spain;Sweden;Switzerland;United Kingdom
5EUCTR2017-001555-32-DE
(EUCTR)
01/02/201812/10/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 Autoimmune Hepatitis (AIH)
MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: anti-BAFFR antibody
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czechia;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden
6EUCTR2017-001555-32-GB
(EUCTR)
16/01/201820/11/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 Autoimmune Hepatitis (AIH)
MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: anti-BAFFR antibody
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2;Phase 3United States;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Netherlands;Germany;Japan;Sweden
7EUCTR2017-001555-32-SE
(EUCTR)
19/12/201702/11/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 Autoimmune Hepatitis (AIH)
MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: anti-BAFFR antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden
8EUCTR2017-001555-32-ES
(EUCTR)
13/11/201711/10/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 Autoimmune Hepatitis (AIH)
MedDRA version: 20.0;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: Not established
Other descriptive name: anti-BAFFr antibody
Novartis Farmacéutica S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden
9EUCTR2017-001555-32-CZ
(EUCTR)
13/10/2017A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liverA 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 Autoimmune Hepatitis (AIH)
MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Novartis Pharma AGNULLNAFemale: yes
Male: yes
80Phase 2;Phase 3United States;Czechia;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden