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 | NCT05057468 (ClinicalTrials.gov) | October 20, 2021 | 16/9/2021 | Second-line Treatment of Primary Autoimmune Hemolytic Anemia | Cyclosporine as a Second-line Treatment of Primary Autoimmune Hemolytic Anemia | Primary Autoimmune Hemolytic Anemia | Drug: Cyclosporine;Drug: Rituximab | Assiut University | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 3 | Egypt |
| 2 | NCT05057481 (ClinicalTrials.gov) | September 15, 2021 | 16/9/2021 | Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus | Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus | Autoimmune Hemolytic Anemia;Systemic Lupus Erythematosus | Drug: Mycophenolate Mofetil 500mg;Drug: Rituximab | Assiut University | NULL | Active, not recruiting | 18 Years | N/A | All | 30 | Phase 3 | Egypt |
| 3 | EUCTR2016-002478-11-AT (EUCTR) | 19/07/2016 | 01/07/2016 | Very low doses of Rituximab for autoimmune diseases, for which rituximab is not approved for - a Pilot Trial | Very low doses of Rituximab for off-label treatment – a Pilot Trial - Low_Rituximab | Autoimmune-haemolytic AnemiaAntiphospholipid SyndromeImmune-mediated Thrombocytopenia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000154058 MedDRA version: 20.0;Classification code 10023095;Term: ITP;System Organ Class: 100000157088 MedDRA version: 20.0;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Mabthera or biosimilar Rituximab Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB Other descriptive name: Rituximab | Medical University of Vienna, Department of Internal medicine I | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Austria | ||
| 4 | EUCTR2011-004835-30-FI (EUCTR) | 10/07/2013 | 17/06/2013 | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 | Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Levact INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE Trade Name: MabThera INN or Proposed INN: RITUXIMAB | Department of Medicine, Haugesund Hospital | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Finland;Denmark;Norway | ||
| 5 | EUCTR2011-004835-30-DK (EUCTR) | 17/01/2013 | 30/11/2012 | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 | Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Levact INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE Trade Name: MabThera INN or Proposed INN: RITUXIMAB | Department of Medicine, Haugesund Hospital | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Finland;Denmark;Norway | ||
| 6 | NCT02689986 (ClinicalTrials.gov) | January 2013 | 16/2/2016 | Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease | The CAD5 Study::Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicenter Trial on the Safety and Efficacy of Bendamustine and Rituximab Combination Therapy | Cold Agglutinin Disease;Autoimmune Hemolytic Anemia | Drug: Bendamustine, Rituximab | Helse Fonna | NULL | Completed | 18 Years | N/A | All | 43 | Phase 2 | Denmark;Finland;Norway |
| 7 | EUCTR2011-004835-30-NO (EUCTR) | 23/10/2012 | 29/08/2012 | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 | Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Levact INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE Trade Name: MabThera INN or Proposed INN: RITUXIMAB | Department of Medicine, Haugesund Hospital | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Finland;Denmark;Norway | ||
| 8 | NCT01181154 (ClinicalTrials.gov) | March 3, 2011 | 12/8/2010 | Rituximab in Auto-Immune Hemolytic Anemia | Rituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled Trial | Warm Autoimmune Hemolytic Anemia | Drug: rituximab (Mabthera®);Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Hoffmann-La Roche | Completed | 18 Years | N/A | All | 32 | Phase 3 | France |
| 9 | NCT00960713 (ClinicalTrials.gov) | June 2009 | 16/7/2009 | The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders | The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders | Pemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;Cryoglobulinemia | Drug: Rituximab (MABTHERA® or RITUXAN®). | University Hospital, Toulouse | NULL | Completed | 18 Years | N/A | Both | 35 | N/A | France |
| 10 | NCT01345708 (ClinicalTrials.gov) | January 2009 | 28/4/2011 | A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia | A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Disease (Cold Type) (Warm Type) | Drug: prednisone, low dose rituximab | Fondazione Ospedale | University Hospital, Udine, Italy | Completed | 18 Years | N/A | Both | 23 | Phase 2 | Italy |
| 11 | EUCTR2008-006713-25-IT (EUCTR) | 23/09/2008 | 16/01/2009 | A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND | A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND | ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHE | INN or Proposed INN: Rituximab | OSPEDALE MAGGIORE DI MILANO (IRCCS) | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 12 | NCT00373594 (ClinicalTrials.gov) | June 2005 | 7/9/2006 | Therapy for Chronic Cold Agglutinin Disease | Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicentre Study on the Safety and Efficacy of Rituximab in Combination With Fludarabine. | Cold Agglutinin Disease | Drug: Rituximab;Drug: Fludarabine | University of Bergen | NULL | Completed | 18 Years | 90 Years | Both | 30 | Phase 2 | Norway;Russian Federation |
| 13 | NCT01134432 (ClinicalTrials.gov) | March 2005 | 28/5/2010 | Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia | Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial. | Anemia, Hemolytic, Autoimmune | Drug: prednisolone + mabthera;Drug: Prednisolone | Copenhagen University Hospital at Herlev | NULL | Completed | 18 Years | N/A | Both | 65 | Phase 3 | Denmark |