65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details


臨床試験数 : 482 薬物数 : 661 - (DrugBank : 119) / 標的遺伝子数 : 90 - 標的パスウェイ数 : 211

  
7 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-000468-41-FR
(EUCTR)
12/01/202102/12/2020Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIAn open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of safety and efficacy of CDZ173 in patients with APDS/PASLI APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
42Phase 2;Phase 3United States;Belarus;France;Czechia;Czech Republic;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy
2EUCTR2016-000468-41-GB
(EUCTR)
25/02/201912/03/2018Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIAn open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patientswith APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of safety and efficacy of CDZ173 in patients with APDS/PASLI APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2;Phase 3United States;Belarus;Czechia;Czech Republic;Ireland;Russian Federation;Netherlands;Italy;United Kingdom
3EUCTR2016-000468-41-IE
(EUCTR)
25/10/201827/02/2018Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIAn open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of safety and efficacy of CDZ173 in patients with APDS/PASLI APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
42Phase 2;Phase 3France;United States;Belarus;Czechia;Czech Republic;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy
4EUCTR2016-000468-41-IT
(EUCTR)
01/06/201802/09/2021Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIAn open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of efficacy of CDZ173 in patients with APDS/PASLI APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Product Name: Leniolisib
Product Code: [CDZ173]
INN or Proposed INN: leniolisib
NOVARTIS PHARMA SERVICES AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2;Phase 3France;United States;Belarus;Czechia;Czech Republic;Ireland;Russian Federation;Germany;Netherlands;United Kingdom;Italy
5EUCTR2016-000468-41-NL
(EUCTR)
03/11/201619/09/2016Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIAn open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of efficacy of CDZ173 in patients with APDS/PASLI APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2;Phase 3France;United States;Belarus;Czechia;Czech Republic;Ireland;Russian Federation;Germany;Netherlands;United Kingdom;Italy
6EUCTR2016-000468-41-CZ
(EUCTR)
19/07/201625/05/2016Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIAn open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of safety and efficacy of CDZ173 in patients with APDS/PASLI APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2;Phase 3France;United States;Belarus;Czechia;Czech Republic;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy
7EUCTR2016-000468-41-DE
(EUCTR)
20/01/2021Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLIAn open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of safety and efficacy of CDZ173 in patients with APDS/PASLI APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Leniolisib
Product Code: CDZ173
INN or Proposed INN: leniolisib
Pharming Technologies B.V.NULLNAFemale: yes
Male: yes
42Phase 2;Phase 3France;United States;Belarus;Czechia;Czech Republic;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy