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 | EUCTR2021-003160-27-HU (EUCTR) | 19/04/2022 | 23/02/2022 | A Randomized, Double-blind, Placebo-controlled Study to Evaluate Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD)” | A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) | Patients with Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: APL-2 Product Name: PEGCETACOPLAN (APL-2) Product Code: 2019171-69-6 INN or Proposed INN: Pegcetacoplan | Swedish Orphan Biovitrum AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Bulgaria;Georgia;Germany;Norway;Japan | ||
| 2 | EUCTR2021-003160-27-ES (EUCTR) | 04/04/2022 | 05/04/2022 | A Randomized, Double-blind, Placebo-controlled Study to Evaluate Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD)” | A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) | Patients with Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: APL-2 Product Name: PEGCETACOPLAN (APL-2) Product Code: 2019171-69-6 INN or Proposed INN: Pegcetacoplan | Swedish Orphan Biovitrum AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Canada;Bulgaria;Georgia;Germany;Norway;Japan | ||
| 3 | EUCTR2017-003363-35-IT (EUCTR) | 05/07/2018 | 04/11/2020 | Clinical study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | An open label, prospective, study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD). - Treatment of wAIHA with APL-2 | Patients affected by Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) MedDRA version: 20.0;Level: LLT;Classification code 10002045;Term: Anaemia haemolytic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: APL-2 Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: APL-2 | APELLIS PHARMACEUTCIALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | United States;Italy | ||
| 4 | NCT03226678 (ClinicalTrials.gov) | August 31, 2017 | 7/7/2017 | Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | An Open Label, Prospective, Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | Warm Autoimmune Hemolytic Anemia;Cold Agglutinin Disease | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States |