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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |