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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-002844-66-DE (EUCTR) | 30/05/2022 | 20/09/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia (PATHWAY) - PATHWAY | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: INCB050465 INN or Proposed INN: Paraclisib Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: INCB050465 INN or Proposed INN: Paraclisib Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Japan;Ukraine;United Kingdom;Spain;Canada;Austria;Netherlands;Belgium;Poland;Italy;Israel;France;Germany | ||
| 2 | EUCTR2021-002844-66-NL (EUCTR) | 10/03/2022 | 29/11/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: INCB050465 INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: INCB050465 INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Canada;Belgium;Poland;Netherlands;Germany;Japan | ||
| 3 | EUCTR2021-002844-66-ES (EUCTR) | 03/02/2022 | 15/10/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: INCB050465 INN or Proposed INN: Parsaclisib Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: INCB050465 INN or Proposed INN: Parsaclisib Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;Japan | ||
| 4 | JPRN-jRCT2051210140 | 30/12/2021 | 24/12/2021 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia - PATHWAY | Warm Autoimmune Hemolytic Anemia (wAIHA) | Group A: Parsaclisib (INCB050465) will be administered QD orally. Group B: Placebo will be administered QD orally. | Ueda Eiji | NULL | Recruiting | >= 18age old | <= 99age old | Both | 100 | Phase 3 | U.S.A;Japan |
| 5 | EUCTR2021-002844-66-IT (EUCTR) | 23/11/2021 | 23/09/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia - NA | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: [INCB050465] Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: [INCB050465] Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: trimethoprim-sulfamethoxazole Product Code: [trimethoprim-sulfamethoxazole] INN or Proposed INN: TRIMETOPRIM + SULFAMETOSSAZOLO * Product Name: pentamidine Product Code: [pentamidine] INN or Proposed INN: PENTAMIDINA ISETIONATO Product Name: atovaquone Product Code: [atovaquone] INN or Proposed INN: ATOVAQUONE | INCYTE CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;Japan | ||
| 6 | NCT03538041 (ClinicalTrials.gov) | November 21, 2018 | 15/5/2018 | A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Anemia | Drug: Parsaclisib | Incyte Corporation | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States;Austria;France;Italy |
| 7 | EUCTR2017-003652-22-IT (EUCTR) | 18/09/2018 | 15/01/2021 | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia - A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) | Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia.Warm AIHA, Cold AIHA MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: INCB050465 2.5 mg Product Code: [INCB050465 2.5 mg] Product Name: INCB050465 1 mg Product Code: [INCB050465 1 mg] | INCYTE CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | France;United States;Austria;Italy | ||
| 8 | EUCTR2017-003652-22-AT (EUCTR) | 18/07/2018 | 29/03/2018 | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia.Warm AIHA, Cold AIHA MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: INCB050465 1 mg INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE Product Code: INCB050465 2.5 mg INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Coorporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | France;United States;Austria;Italy |