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 | NCT05325593 (ClinicalTrials.gov) | December 2, 2022 | 7/3/2022 | Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia | A Multicentre, Randomized, Open-label Study of Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Drug: romiplostim plus dexamethasone;Drug: Dexamethasone | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | NULL | Recruiting | 18 Years | N/A | All | 126 | Phase 3 | Spain |
| 2 | NCT04812483 (ClinicalTrials.gov) | September 1, 2022 | 1/3/2021 | Immunomodulation With Eltrombopag in ITP | Immunomodulation in Young and Midlife Adults With Newly Diagnosed Primary Immune Thrombocytopenia (ITP): A Randomized Open Label Trial With High-dose Dexamethasone Versus Eltrombopag and High-dose Dexamethasone | Primary Immune Thrombocytopenia (ITP) | Drug: Eltrombopag (Revolade®);Drug: standard therapy (without eltrombopag): HD-DXM | University Children's Hospital Basel | Stiftung zur Förderung medizinischer und biologischer Forschung;Novartis Pharmaceuticals;University of Erlangen-Nürnberg, Department of Biology | Recruiting | 18 Years | 55 Years | All | 24 | Phase 2 | Switzerland |
| 3 | ChiCTR2100053604 | 2022-01-01 | 2021-11-24 | A clinical study of the efficacy of low-dose prednisone maintenance therapy on adult patients with relapsed chronic/persistent primary immune thrombocytopenia | A clinical study of the efficacy of low-dose prednisone maintenance therapy on adult patients with relapsed chronic/persistent primary immune thrombocytopenia | Primary immune thrombocytopenia | Experimental group:High-dose dexamethasone followed by low-dose prednisone maintenance treatment;Control group:Placebo-controlled after high-dose dexamethasone treatment; | The Second Affiliated Hospital of Guangxi Medical University | NULL | Recruiting | 18 | 60 | Both | Experimental group:113;Control group:113; | Phase 4 | China |
| 4 | NCT03692754 (ClinicalTrials.gov) | November 1, 2021 | 29/9/2018 | Atorvastatin in Management of Newly Diagnosed ITP | A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia;Purpura, Thrombocytopenic | Drug: Atorvastatin 20mg;Drug: Atorvastatin 10mg;Drug: Dexamethasone | Shandong University | NULL | Not yet recruiting | 18 Years | 80 Years | All | 30 | Phase 2/Phase 3 | China |
| 5 | NCT05023915 (ClinicalTrials.gov) | August 21, 2021 | 21/8/2021 | A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP | High-dose Dexamethasone Plus Diammonium Glycyrrhizinate Enteric-coated Capsule Versus High-dose Dexamethasone in Treatment-naive Primary Immune Thrombocytopenia (ITP): a Multicentre, Randomised, Open-label Trial | Immune Thrombocytopenia | Drug: dexamethasone;Drug: diammonium glycyrrhizinate enteric-coated capsule | Shandong University | NULL | Recruiting | 18 Years | 80 Years | All | 106 | Phase 2 | China |
| 6 | ChiCTR2100045747 | 2020-12-01 | 2021-04-23 | Efficacy and safety study of corticosteroids plus hydroxychloroquine in first-line treatment of patients with primary immune thrombocytopenia with positive antinuclear antibody | Efficacy and safety study of corticosteroids plus hydroxychloroquine in first-line treatment of patients with primary immune thrombocytopenia with positive antinuclear antibody | primary immune thrombocytopenia | Experimental group:hydroxychloroquine + Dexamethasone;Control group:Dexamethasone; | Jinshan Hospital, Fudan University | NULL | Recruiting | 18 | Both | Experimental group:51;Control group:51; | Phase 4 | China | |
| 7 | 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 |
| 8 | ChiCTR1900027735 | 2020-01-01 | 2019-11-24 | Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP) | Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP) | Adult newly diagnosed immune thrombocytopenia | Study group:Dexamethasone 40mg/d×4d, recombinant human thrombopoietin (rhTPO) 300U/Kg subcutaneous injection, once/d×14d, if PLT>100×109/L or PLT increase =50×109/L during treatment period RhTPO drug was discontinued; rhTPO and dexamethasone were replaced with prednisone 0.5mg~1mg/kg once a day, 0.2mg/kg per week, and the drug was stopped wit;Control group:Dexamethasone 40mg/d×4d, if the PLT>100×10^9/L or PLT increase =50×10^9/L during the treatment period, dexamethasone was replaced with prednisone 0.5mg~ 1mg/kg orally every day, reduce 0.2mg/kg per week, and quickly reduce the dose within 6~8 weeks.; | Department of Hematology, Anhui Provincial Hospital | NULL | Pending | 18 | 80 | Both | Study group:30;Control group:30; | Phase 4 | China |
| 9 | JPRN-jRCTs041190069 | 01/10/2019 | 25/09/2019 | Clinical study to evaluate the efficacy of dexamethasone Palmitate for idiopathic (immune) thrombocytopenic purpura: ITP. | Clinical Investigation to evaluate the efficacy of dexamethasone palmitate for idiopathic (immune) thrombocytopenic purpura: ITP. - Clinical investigation of Dexamethasone Palmitate for ITP | Chronic Idiopathic Thrombocytopenic Purpura refractory, immune, thrombocytopenia,;D016553 | Administration of dexamethasone palmitate (5mg/day for 4 days) | Nakayama Takayuki | NULL | Recruiting | >= 20age old | <= 75age old | Both | 7 | Phase 1 | Japan |
| 10 | NCT03998982 (ClinicalTrials.gov) | June 25, 2019 | 25/6/2019 | Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP | A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Drug: Glycyrrhetinic Acid;Drug: Dexamethasone | Shandong University | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 4 | China |
| 11 | NCT03252457 (ClinicalTrials.gov) | September 1, 2018 | 14/8/2017 | Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP | A Multicenter Prospective Randomized Study of Dexamethasone Combined With Decitabine Versus Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) | Purpura, Thrombocytopenic, Idiopathic;Immune Thrombocytopenia | Drug: Decitabine;Drug: Dexamethasone | Shandong University | Second Affiliated Hospital of Medical College Shandong University;Shandong Provincial Hospital;Qingdao Central Hospital;Chinese Academy of Medical Sciences | Not yet recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | China |
| 12 | NCT03830749 (ClinicalTrials.gov) | July 1, 2018 | 1/2/2019 | Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura | A Pilot Study to Evaluate the Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone as First Line Therapy for Subjects With Idiopathic Thrombocytopenic Purpura (ITP) | Immune Thrombocytopenia | Drug: Eltrombopag | Humanity & Health Medical Group Limited | NULL | Suspended | 18 Years | N/A | All | 60 | Phase 2 | Hong Kong |
| 13 | 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 | ||
| 14 | NCT02914054 (ClinicalTrials.gov) | October 1, 2016 | 19/9/2016 | Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone | Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM) | ITP;Croticosteroid Therapy | Drug: High dose Dexamethasone pulses;Drug: Prednisone | Isfahan University of Medical Sciences | Adibvira | Completed | 18 Years | N/A | All | 36 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 15 | NCT02642380 (ClinicalTrials.gov) | November 2015 | 24/12/2015 | Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP) | Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial | Immune Thrombocytopenia | Drug: Dexamethasone (4 cycles);Drug: Dexamethasone (1 cycle) | Shandong University | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 4 | China |
| 16 | NCT02556814 (ClinicalTrials.gov) | September 2015 | 21/9/2015 | Caffeic Acid Combining High-dose Dexamethasone in Management of ITP | A Prospective, Multicenter, Placebo Controlled Study on Caffeic Acid Tablet Combining High-dose Dexamethasone in Management of Adult Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Drug: Caffeic acid tablets;Drug: Dexamethasone;Drug: placebo | Shandong University | NULL | Completed | 18 Years | 75 Years | All | 214 | Phase 4 | China |
| 17 | ChiCTR1900021211 | 2015-04-01 | 2019-02-01 | A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP) | A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP) | immune thrombocytopenia (ITP) | 1:eltrombopag 25-75mg daily for 3 months plus pulsed dexamethasone, 40mg daily for 4 days repeated every 4 weeks for 1-3 courses; | University Hospital, Macau | NULL | Recruiting | 18 | 100 | Both | 1:60; | China | |
| 18 | NCT01882127 (ClinicalTrials.gov) | February 2013 | 19/4/2013 | All-Trans Retinoic Acid (ATRA) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | Clinical Study on All-Trans Retinoic Acid (ATRA) Combining High-dose Dexamethasone Versus High-dose Dexamethasone Alone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: All-Trans Retinoid Acid(ATRA);Drug: Dexamethasone | Shandong University | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 3 | China |
| 19 | NCT01734044 (ClinicalTrials.gov) | July 2012 | 21/11/2012 | rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP | A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: recombinant human thrombopoietin (rhTPO); dexamethasone;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 | Completed | 18 Years | 75 Years | Both | 158 | Phase 3 | China |
| 20 | 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 |
| 21 | NCT01356511 (ClinicalTrials.gov) | September 2010 | 17/5/2011 | High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial | Purpura, Thrombocytopenic, Idiopathic | Drug: Prednisone;Drug: Dexamethasone | Shandong University | Chinese Academy of Medical Sciences;Peking Union Medical College Hospital;Ruijin Hospital;Wuhan Union Hospital, China;Tongji Hospital;Shandong University of Traditional Chinese Medicine;Anhui Provincial Hospital;Zhejiang Provincial Hospital of TCM;Second Hospital of Shanxi Medical University;Xinjiang Uygur Autonomous Region People's Hospital;Shenzhen Second People's Hospital | Completed | 18 Years | 80 Years | Both | 261 | Phase 4 | China |
| 22 | EUCTR2008-000417-30-IT (EUCTR) | 19/06/2008 | 11/04/2008 | Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207 | Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207 | ITP Primary Immune Thrombocytopenic Purpura in newly diagnosed untreated adult patients MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Dexamethasone INN or Proposed INN: Dexamethasone Product Name: Prednisone INN or Proposed INN: Prednisone | G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 23 | NCT00451594 (ClinicalTrials.gov) | September 2005 | 22/3/2007 | High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP | A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura | Drug: Dexamethasone;Drug: Prednisolone | Cooperative Study Group A for Hematology | NULL | Completed | 16 Years | N/A | Both | 157 | Phase 3 | Korea, Republic of |
| 24 | 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 |
| 25 | 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 | ||||
| 26 | 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 |