61. 自己免疫性溶血性貧血 Autoimmune hemolytic anemia Clinical trials / Disease details
臨床試験数 : 137 / 薬物数 : 127 - (DrugBank : 55) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 153
| 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 | NCT05221619 (ClinicalTrials.gov) | February 10, 2022 | 5/1/2022 | Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) | Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006 | Anemia, Hemolytic, Autoimmune | Drug: Nipocalimab | Janssen Research & Development, LLC | NULL | Available | N/A | N/A | All | NULL | ||
| 2 | EUCTR2019-000720-17-NL (EUCTR) | 31/03/2020 | 16/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Netherlands;Germany | ||
| 3 | EUCTR2019-000720-17-DE (EUCTR) | 14/01/2020 | 05/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 4 | EUCTR2019-000720-17-GR (EUCTR) | 27/12/2019 | 08/10/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 5 | EUCTR2019-000720-17-HU (EUCTR) | 05/11/2019 | 06/11/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10073784;Term: Anemia hemolytic autoimmune;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 6 | NCT04119050 (ClinicalTrials.gov) | October 24, 2019 | 18/9/2019 | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension | Warm Autoimmune Hemolytic Anemia | Drug: M281;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 111 | Phase 2/Phase 3 | United States;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Poland;Spain;Ukraine;United Kingdom |
| 7 | EUCTR2019-000720-17-FR (EUCTR) | 15/10/2019 | 17/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2;Phase 3 | Netherlands;Germany;United Kingdom;Italy;United States;France;Hungary;Czech Republic;Greece;Spain;Poland;Denmark | ||
| 8 | EUCTR2019-000720-17-PL (EUCTR) | 09/10/2019 | 27/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: Not Applicable Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 9 | EUCTR2019-000720-17-ES (EUCTR) | 19/09/2019 | 27/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2;Phase 3 | France;United States;Hungary;Czech Republic;Greece;Poland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2019-000720-17-IT (EUCTR) | 16/09/2019 | 27/01/2021 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study with a Long-term Open-label Extension - --- | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M281 Product Code: [M281] INN or Proposed INN: M281 Other descriptive name: M281 | MOMENTA PHARMACEUTICALS, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 11 | EUCTR2019-000720-17-CZ (EUCTR) | 10/09/2019 | 10/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands;United States;Czechia;Greece;Spain |