61. 自己免疫性溶血性貧血 Autoimmune hemolytic anemia Clinical trials / Disease details


臨床試験数 : 146 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-002039-40-IT
(EUCTR)
08/02/202201/10/2021Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disordersAn open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders - -- Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD)
MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: HAEMOPHILUS INFLUENZAE
Trade Name: BEXSERO – Sospensione iniettabile – Siringa preriempita
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B
Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO HAEMOPHILUS INFLUENZAE B CONIUGATO CON TOSSOIDETETANICO
Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
Trade Name: Nimenrix
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Spain;Korea, Democratic People's Republic of;Germany;United Kingdom;Italy
2NCT05086744
(ClinicalTrials.gov)
December 21, 202128/9/2021Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological DisordersAn Open-label, Multi-center, Phase 2 Basket Study to Assess Efficacy, Safety and Pharmacokinetics of Iptacopan (LNP023) in Participants With Autoimmune Benign Hematological DisordersImmune Thrombocytopenia (ITP);Cold Agglutinin Disease (CAD)Drug: IptacopanNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll30Phase 2United States;Germany;Italy;Korea, Republic of;Spain;United Kingdom
3EUCTR2021-002039-40-ES
(EUCTR)
02/11/202103/11/2021Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disordersAn open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD)
MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of
4EUCTR2021-002039-40-DE
(EUCTR)
29/10/202114/09/2021Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disordersAn open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD)
MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of