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 | NCT04691570 (ClinicalTrials.gov) | November 10, 2021 | 28/12/2020 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Intravenous ANX005 in Subjects With Warm Autoimmune Hemolytic Anemia (wAIHA) | Warm Autoimmune Hemolytic Anemia (wAIHA) | Drug: ANX005 | Annexon, Inc. | NULL | Completed | 18 Years | N/A | All | 6 | Phase 2 | United States |
| 2 | EUCTR2020-003675-18-BG (EUCTR) | 28/10/2021 | 29/07/2021 | Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHA | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia | 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] - Blood and lymphatic diseases [C15] | Product Code: ANX005 INN or Proposed INN: ANX005 Other descriptive name: ANX005 | Annexon, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;France;Czechia;Spain;Austria;Australia;Bulgaria;Germany;Italy | ||
| 3 | EUCTR2020-005854-90-AT (EUCTR) | 11/02/2021 | 05/01/2021 | Investigation of the influence of ANX005 on the body of patients with primary cold agglutinin disease in terms of safety and tolerability. A Phase 2, single-center, open-label, repeat-dose study. | A Phase 2, Single-Center, Open-Label, Repeat-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of Intravenous ANX005 in Participants with Primary Cold Agglutinin Disease | Primary Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ANX005 INN or Proposed INN: ANX005 Other descriptive name: Recombinant humanized IgG4 monoclonal antibody | Annexon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Austria | ||
| 4 | EUCTR2020-003675-18-AT (EUCTR) | 05/02/2021 | 10/12/2020 | Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHA | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia | 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] - Blood and lymphatic diseases [C15] | Product Code: ANX005 INN or Proposed INN: ANX005 Other descriptive name: ANX005 | Annexon, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Czechia;Spain;Australia;Austria;Bulgaria;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2020-003675-18-DE (EUCTR) | 11/01/2021 | 28/09/2020 | Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHA | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia | 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] - Blood and lymphatic diseases [C15] | Product Code: ANX005 INN or Proposed INN: ANX005 Other descriptive name: ANX005 | Annexon, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Czechia;Spain;Austria;Australia;Bulgaria;Germany;Italy | ||
| 6 | EUCTR2020-003675-18-IT (EUCTR) | 11/12/2020 | 02/08/2021 | Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHA | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia - Study with intravenous ANX005 in patients with wAIHA | 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] - Blood and lymphatic diseases [C15] | Product Name: ANX005 Product Code: [ANX005] Other descriptive name: Recombinant humanized monoclonal antibody: IgG4 (heavy chain); kappa (light chain) | Annexon, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;Hungary;Spain;Austria;Norway;Netherlands;Germany;United Kingdom;Italy |