63. 特発性血小板減少性紫斑病 Idiopathic thrombocytopenic purpura Clinical trials / Disease details
臨床試験数 : 391 / 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
| 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 | ChiCTR2200057058 | 2022-07-01 | 2022-02-27 | A Single-Arm Prospective Exploratory Clinical Study Of Zanubrutinib Combined With Rituximab In The Treatment Of Steroid-Ineffective Primary Immune Thrombocytopenia | A Single-Arm Prospective Exploratory Clinical Study Of Zanubrutinib Combined With Rituximab In The Treatment Of Steroid-Ineffective Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Therapy Group:Zanubrutinib (80 mg, 2 times/day, for a total of 12 weeks) combined with Rituximab (375 mg/m2, 1 intravenous infusion) regimen; | The Second Affiliated Hospital of Kunming Medical University | NULL | Pending | 18 | 70 | Both | Therapy Group:23; | Phase 1 | China |
| 2 | NCT05338190 (ClinicalTrials.gov) | June 1, 2022 | 21/3/2022 | Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia | A Phase 3 Randomized and Double-blind Controlled Trial Comparing the Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition to Rituximab in Adult Patients With Persistent or Chronic Immune Thrombocytopenia (ITP) | Primary Immune Thrombocytopenia (ITP) | Drug: Combination of Rituximab with subcutaneous belimumab;Drug: Combination of Rituximab with subcutaneous placebo | Assistance Publique - Hôpitaux de Paris | GlaxoSmithKline | Not yet recruiting | 18 Years | N/A | All | 132 | Phase 3 | NULL |
| 3 | ChiCTR2000035408 | 2020-08-20 | 2020-08-10 | A randomized controlled study for rituximab in first-line treatment of newly diagnosed immune thrombocytopenia | Study of rituximab in first-line treatment of newly diagnosed immune thrombocytopenia | Idiopathic Thrombocytopenic Purpura | Standard dose group:Rituximab (Hanrikang) 375mg/m2, 4 times a week (day 8, 15, 22, 29).;Low-dose group:Rituximab (Hanrikang) 100mg/ time once a week, administered 4 times (day 8, 15, 22 and 29).;Dexamethasone control group:high-dose dexamethasone (HD-DXM), 40mg/d, iv for 4 days (day 1 to day 4), every 15 days, 2 to 4 cycles, until CR or the end of the study.; | Henan Cancer Hospital | NULL | Recruiting | 18 | 65 | Both | Standard dose group:20;Low-dose group:20;Dexamethasone control group:20; | Phase 4 | China |
| 4 | NCT04518475 (ClinicalTrials.gov) | August 10, 2020 | 12/8/2020 | Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults | A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients | Primary Immune Thrombocytopenia (ITP) | Drug: eltrombopag combining rituximab;Drug: eltrombopag | Institute of Hematology & Blood Diseases Hospital | The Second Affiliated Hospital of Kunming Medical University;Henan Cancer Hospital;Tianjin Medical University Second Hospital;The First Affiliated Hospital of Xiamen University;Nantong University | Recruiting | 18 Years | 60 Years | All | 224 | Phase 4 | China |
| 5 | ChiCTR2000030603 | 2020-05-01 | 2020-03-08 | A multicenter prospective cohort clinical study of a short-course glucocorticoid therapy regimen for glucocorticoid-dependent immune thrombocytopenia | A multicenter prospective cohort clinical study of a short-course glucocorticoid therapy regimen for glucocorticoid-dependent immune thrombocytopenia | Primary Immune Thrombocytopenia | The short -course glucocorticoid group:treat with glucocorticoid;The eltrombopag group:treat with eltrombopag;The rituximab group:treat with rituximab;Splenectomy group:treat with splenectomy;The azathioprine group:treat with azathioprine;The cyclosporine group:treat with cyclosporine; | The Second Affiliated Hospital of Kunming Medical University | NULL | Recruiting | 18 | 75 | Both | The short -course glucocorticoid group:65;The eltrombopag group:65;The rituximab group:65;Splenectomy group:65;The azathioprine group:65;The cyclosporine group:65; | Phase 4 | China |
| 6 | ChiCTR1900027748 | 2020-05-01 | 2019-11-25 | A single-arm multicenter prospective clinical study of rituximab 500 mg/m2 in glucocorticoid-ineffective or glucocorticoid-dependent primary immune thrombocytopenia | A single-arm multicenter prospective clinical study of rituximab 500 mg/m2 in glucocorticoid-ineffective or glucocorticoid-dependent primary immune thrombocytopenia | Primary Immune Thrombocytopenia | Test group:Rituximab (500mg/m2, once intravenously); | Department of Hematology, the Second Affiliated Hospital of Kunming Medical University | NULL | Recruiting | Both | Test group:60; | Phase 4 | China | ||
| 7 | NCT03443570 (ClinicalTrials.gov) | March 1, 2018 | 18/2/2018 | Rituximab Combining Bortezomib Versus Rituximab in Management of ITP | A Multicenter Prospective Randomized Study of Rituximab Combined With Bortezomib Versus Rituximab in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia;Purpura, Thrombocytopenic, Idiopathic | Drug: Rituximab;Drug: Bortezomib | Shandong University | The Affiliated Hospital of Qingdao University;Yantai Yuhuangding Hospital | Not yet recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | China |
| 8 | EUCTR2015-005276-14-DK (EUCTR) | 08/12/2016 | 19/10/2016 | Maintenance treatment With rituximab in ITP | Prolonging the response by low-dose Rituximab maintenance therapy in immune thrombocytopenia: a randomized placebo-controlled trial- the PROLONG trial. - PROLONG-trial | Immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Mabthera Product Name: rituximab Trade Name: Dexamethasone Abcur Product Name: Dexamethasone | Sykehuset Østfold HF | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | France;Egypt;Denmark;Norway;Tunisia | ||
| 9 | NCT01734057 (ClinicalTrials.gov) | July 2012 | 21/11/2012 | Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: recombinant human thrombopoietin (rhTPO); rituximab;Drug: Dexamethasone | Shandong University | The Affiliated Hospital of the Chinese Academy of Military Medical Sciences;Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;China Medical University, China;Zhejiang Provincial Hospital of TCM | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 3 | China |
| 10 | JPRN-JMA-IIA00070 | 31/10/2011 | 12/08/2011 | R-ITP: Clinical Evaluation of Rituximab in Primary Immune Thrombocytopenia | R-ITP: Clinical Evaluation of Rituximab in Primary Immune Thrombocytopenia | Idiopathic Thrombocytopenic Purpura | Intervention type:DRUG. Intervention1:rituximab, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP. | Keio University School of Medicine , Yoshitaka miyakawa | NULL | Completed | >=20 YEARS | No Limit | BOTH | 24 | Phase 3 | Japan |
| 11 | NCT01525836 (ClinicalTrials.gov) | May 2011 | 31/1/2012 | rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP | Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP. | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: rituximab; recombinant human thrombopoietin (rhTPO);Drug: Rituximab | Shandong University | The Affiliated Hospital of the Chinese Academy of Military Medical Sciences;The First Affiliated Hospital of Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;First Hospital of China Medical University | Completed | 18 Years | 72 Years | Both | 123 | Phase 3 | China |
| 12 | NCT03258866 (ClinicalTrials.gov) | January 1, 2010 | 18/8/2017 | The Study of Different Dose Rituximab in the Treatment of ITP | The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia | Purpura, Thrombocytopenic, Idiopathic;Immune Thrombocytopenia | Drug: Rituximab | Shandong University | NULL | Completed | 10 Years | 70 Years | All | 62 | Phase 4 | China |
| 13 | NCT01506414 (ClinicalTrials.gov) | June 2009 | 16/11/2011 | Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP) | A Multicentre Investigation of Recombinant Human Thrombopoietin (Rh-TPO) Combine With Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP) | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: rhTPO in combination with Rituximab | Ming Hou | Peking Union Medical College Hospital;Chinese Academy of Medical Sciences;First Affiliated Hospital, Sun Yat-Sen University;West China Hospital;Shandong Provincial Hospital;Wuhan Union Hospital, China;Zhejiang University | Completed | 16 Years | 75 Years | Both | 91 | Phase 3 | China |
| 14 | EUCTR2005-005918-20-FR (EUCTR) | 23/12/2008 | 23/10/2008 | Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study | Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study | Immune thrombocytopenic purpura (ITP) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: MabThera Product Name: MabThera Other descriptive name: RITUXIMAB | Rikshospitalet | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | France;United Kingdom;Sweden | ||
| 15 | NCT00749112 (ClinicalTrials.gov) | August 2008 | 8/9/2008 | Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias | Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias | Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune | Drug: Alemtuzumab, Rituximab | Hospital Universitario Dr. Jose E. Gonzalez | NULL | Completed | 16 Years | N/A | Both | 19 | Phase 2/Phase 3 | Mexico |
| 16 | NCT00475423 (ClinicalTrials.gov) | May 2007 | 17/5/2007 | A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura. | An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura. | Idiopathic Thrombocytopenic Purpura | Drug: rituximab [MabThera/Rituxan] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 122 | Phase 2 | Australia |
| 17 | NCT00770562 (ClinicalTrials.gov) | July 2005 | 9/10/2008 | A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP) | A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura | Drug: rituximab;Drug: Dexamethasone | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 103 | Phase 3 | Italy |
| 18 | EUCTR2005-000859-15-IT (EUCTR) | 14/04/2005 | 20/06/2005 | Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults. | Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults. | Front-line treatment of adult ITP MedDRA version: 6.1;Level: PT;Classification code 10021245 | Trade Name: Mabthera INN or Proposed INN: Rituximab Trade Name: Mabthera INN or Proposed INN: Rituximab | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 19 | NCT01713855 (ClinicalTrials.gov) | October 2004 | 18/10/2012 | Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura | Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura;Immune Thrombocytopenic Purpura | Biological: Inactivated Trivalent Influenza vaccine | Neufeld, Ellis J, MD, PhD | Terrana ITP Research Fund | Completed | 18 Months | 18 Years | Both | 10 | N/A | United States |
| 20 | NCT00909077 (ClinicalTrials.gov) | August 2004 | 26/5/2009 | The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP) | A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura | Drug: Dexamethasone;Drug: Dexamethasone and Rituximab | Copenhagen University Hospital at Herlev | NULL | Completed | 18 Years | N/A | All | 155 | Phase 3 | Denmark |
| 21 | NCT00161564 (ClinicalTrials.gov) | February 2004 | 8/9/2005 | A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone | A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment | Idiopathic Thrombocytopenic Purpura (ITP) | Drug: Rituximab | Weill Medical College of Cornell University | Genentech, Inc. | Withdrawn | 12 Years | N/A | All | 0 | Phase 2 | United States |
| 22 | NCT01713738 (ClinicalTrials.gov) | May 2003 | 18/10/2012 | Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Open Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)in Children and Adolescents | Idiopathic Thrombocytopenic Purpura (ITP);Immune Thrombocytopenic Purpura (ITP) | Drug: rituximab | Neufeld, Ellis J, MD, PhD | Genentech, Inc.;Biogen Idec;Glaser Pediatric Research Network;Terrana ITP Research Fund | Completed | 18 Months | 18 Years | Both | 36 | Phase 1/Phase 2 | United States |