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 63. 特発性血小板減少性紫斑病 [臨床試験数:127,薬物数:127(DrugBank:32),標的遺伝子数:33,標的パスウェイ数:27] 

Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1NCT04113915November 201911 November 2019Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple TherapyViral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple TherapyITP - Immune Thrombocytopenic Purpura;Viral HepatitisDrug: triple therapy;Drug: SteroidsSafaa AA KhaledNot recruiting18 Years75 YearsAll150Phase 4
2NCT04132050October 31, 201928 October 2019A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788A Phase III Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788Idiopathic Thrombocytopenic PurpuraDrug: R788;Drug: PlaceboKissei Pharmaceutical Co., Ltd.Recruiting20 YearsN/AAll24Phase 3Japan
3JPRN-jRCTs04119006901/10/20197 October 2019Clinical 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 ITPChronic Idiopathic Thrombocytopenic Purpura
refractory, immune, thrombocytopenia,;D016553
Administration of dexamethasone palmitate (5mg/day for 4 days)Takayuki NakayamaRecruiting>= 20age old<= 75age oldBoth7Phase 1none
4NCT03998982June 25, 201915 July 2019Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITPA Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaDrug: Glycyrrhetinic Acid;Drug: DexamethasoneShandong UniversityRecruiting18 Years80 YearsAll30Phase 4China
5NCT03771378January 16, 201928 January 2019Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP)Efficacy and Safety of rhTPO and Eltrombopag in the Treatment of Chinese Adults With Primary Immune Thrombocytopenia (ITP):a Multicenter, Double-blind, Randomized, Controlled TrialPrimary Immune ThrombocytopeniaDrug: rhTPO;Drug: eltrombopagWuhan Union Hospital, ChinaThe First Affiliated Hospital of Nanchang University;The Third Xiangya Hospital of Central South University;The First People's Hospital of Yuhang District;Xiangyang Central HospitalRecruiting18 Years75 YearsAll96Phase 4China
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
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PhaseCountries
6NCT03275740December 20, 201826 August 2019A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-06755347 AFTER SINGLE ASCENDING INTRAVENOUS INFUSIONS TO HEALTHY ADULT MALE PARTICIPANTSPolyradiculoneuropathy, Chronic Inflammatory Demyelinating;Idiopathic Thrombocytopenic PurpuraDrug: PF-06755347;Drug: Placebo comparatorPfizerRecruiting18 Years40 YearsMale64Phase 1Belgium;United States
7NCT03252457September 1, 201827 August 2018Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITPA 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 ThrombocytopeniaDrug: Decitabine;Drug: DexamethasoneShandong UniversitySecond Affiliated Hospital of Medical College Shandong University;Shandong Provincial Hospital;Qingdao Central Hospital;Chinese Academy of Medical SciencesNot recruiting18 Years75 YearsAll200Phase 3China
8NCT03412188August 1, 201827 August 2018The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP.Evaluation of the Effect of Eltrombopag on the Expression of Platelet Collagen Receptor Glycoprotein VI (GPVI) in Pediatric Patients With Chronic and Persistent Immune Thrombocytopenia.Idiopathic Thrombocytopenic PurpuraDrug: Eltrombopag;Drug: conventionalNayera Hazaa ElsherifRecruiting1 Year18 YearsAll40N/AEgypt
9NCT03830749July 1, 201825 February 2019Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic PurpuraA 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 ThrombocytopeniaDrug: EltrombopagHumanity & Health Medical Group LimitedRecruiting18 YearsN/AAll60Phase 2Hong Kong
10NCT03692754June 1, 20189 October 2018Atorvastatin in Management of Newly Diagnosed ITPA Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)Immune Thrombocytopenia;Purpura, ThrombocytopenicDrug: Atorvastatin 20mg;Drug: Atorvastatin 10mgShandong UniversityRecruiting18 Years80 YearsAll30Phase 4China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
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PhaseCountries
11EUCTR2015-003653-17-CZ07/05/201828 February 2019An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)Chronic primary immune thrombocytopenia (ITP)
MedDRA version: 20.0 Level: LLT Classification code 10051057 Term: Idiopathic thrombocytopenia System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IgG Next Generation
Product Code: BT595
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Normal Immunoglobulin (iv)
Current Sponsor code: BT595
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Biotest AGNot Recruiting Female: yes
Male: yes
40Phase 3Hungary;Czech Republic;Spain;Bulgaria;Germany
12NCT03443570March 1, 201826 February 2018Rituximab Combining Bortezomib Versus Rituximab in Management of ITPA 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, IdiopathicDrug: Rituximab;Drug: BortezomibShandong UniversityThe Affiliated Hospital of Qingdao University;Yantai Yuhuangding HospitalNot recruiting18 Years75 YearsAll200Phase 3China
13ChiCTR-OON-170141652018-01-018 January 2018A clinical trial to evaluate the efficacy and safety of corticosteroids combined with cyclosporin A in the treatment of primary immune thrombocytopeniaA clinical trial to evaluate the efficacy and safety of corticosteroids combined with cyclosporin A in the treatment of primary immune thrombocytopeniaImmune Thrombocytopeniaone:Corticosteroids;two:Corticosteroids combined with Cyclosporin A ;Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting1865Bothone:100;two:100;OtherChina
14NCT03201848November 16, 20174 November 2019The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune ThrombocytopeniaA Multisite, Randomized, Double-Blind, Placebo-Controlled, and Parallel Study to Evaluate the Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia (Qi Yin Deficiency)Immune ThrombocytopeniaDrug: Placebo;Drug: Huaiqihuang GranuleQidong Gaitianli Medicines Co., LtdHuazhong University of Science and TechnologyRecruiting1 Year14 YearsAll216Phase 4China
15ChiCTR-ONC-170121262017-09-0121 August 2017A multicenter, prospective, one-arm clinical study of Sirolimus treats refractory and recurrence primary immune thrombocytopeniaA multicenter, prospective, one-arm clinical study of Sirolimus treats refractory and recurrence primary immune thrombocytopeniarefractory or recurrence primary immune thrombocytopeniaCase series:Sirolimus treats refractory or recurrence primary immune thrombocytopenia;Department of Hematology, Xiniao HospitalNot Recruiting1880BothCase series:103;New Treatment Measure Clinical StudyChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
16NCT03222843June 30, 201716 December 2017Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) PatientA Phase III,Multicentre, Randomized, Double-Blind and Open-Label Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Idiopathic Thrombocytopenic PurpuraIdiopathic Thrombocytopenic PurpuraDrug: Hetrombopag Olamine;Drug: matching placeboJiangsu HengRui Medicine Co., Ltd.Recruiting18 YearsN/AAll414Phase 3China
17ChiCTR-ONC-170132302017-05-206 November 2017A single center, one-arm, and open clinical study of PKA agonist (aminophylline) with conventional treatment for chronic or refractory primary immune thrombocytopeniaA single center, one-arm, and open clinical study of PKA agonist (aminophylline) with conventional treatment for chronic or refractory primary immune thrombocytopeniaprimary immune thrombocytopeniaCase series:PKA agonist (aminophylline) treats chronic or refractory primary immune thrombocytopenia;Department of Hematology, The First Affiliated Hospital of Soochow UniversityNot Recruiting1165BothCase series:60;New Treatment Measure Clinical StudyChina
18NCT03102593March 13, 201720 May 2019A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITPA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaDrug: ARGX-113;Other: Placeboargenx BVBAQuintiles, Inc.Not recruiting18 Years85 YearsAll38Phase 2Austria;Belgium;Czechia;France;Germany;Hungary;Poland;Spain;Ukraine;United Kingdom;Czech Republic
19EUCTR2016-003038-26-GB08/02/20177 January 2019A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune ThrombocytopeniaA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia, followed by an Open-Label Treatment Period - ARGX-113-1603_Argenx BVBAPrimary Immune Thrombocytopenia
MedDRA version: 20.1 Level: LLT Classification code 10074678 Term: Primary immune thrombocytopenic purpura System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: N/A
CAS Number: 1821402-21-4
Current Sponsor code: ARGX-113
Other descriptive name: ARGX-113
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Argenx BVBAAuthorisedFemale: yes
Male: yes
36Phase 2France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
20EUCTR2015-003653-17-DE27/01/201730 April 2019An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)Chronic primary immune thrombocytopenia (ITP)
MedDRA version: 19.0 Level: LLT Classification code 10051057 Term: Idiopathic thrombocytopenia System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IgG Next Generation
Product Code: BT595
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Normal Immunoglobulin (iv)
Current Sponsor code: BT595
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Biotest AGNot Recruiting Female: yes
Male: yes
40Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
21EUCTR2015-005276-14-DK08/12/201620 February 2017Maintenance treatment With rituximab in ITPProlonging the response by low-dose Rituximab maintenance therapy in immune thrombocytopenia: a randomized placebo-controlled trial- the PROLONG trial. - PROLONG-trialImmune thrombocytopenia
MedDRA version: 19.0 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 500 mg/50 ml-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Dexamethasone Abcur
Product Name: Dexamethasone
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4 mg/ tbl.-
Sykehuset Østfold HFAuthorisedFemale: yes
Male: yes
100Phase 3France;United States;Denmark;Norway;Tunisia;United Kingdom
22NCT02859909November 201626 August 2019This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)An Open Label, Prospective, Randomized, Multicenter Study Investigating Clinical Efficacy and Safety of the Human Normal Immunoglobulin for Intravenous Administration BT595 in Patients With Chronic Primary Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaBiological: BT595BiotestSyneos HealthNot recruiting18 Years75 YearsAll34Phase 3Bulgaria;Czechia;Germany;Hungary;Serbia;Spain
23ChiCTR-INR-160093632016-10-1318 April 2017'Yu Xue Qi Huo' theory based integrated Traditional Chinese and Western Medicine in the diagnosis and treatment of stratified relapsed and refractory primary immune thrombocytopenia'Yu Xue Qi Huo' theory based integrated Traditional Chinese and Western Medicine in the diagnosis and treatment of stratified relapsed and refractory primary immune thrombocytopeniaImmune ThrombocytopeniaStudy Group A:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously;Study Group A:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration;Control group B:Traditional Chinese Medicine for control group;Control group B:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration ;Study Group C:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously ;Study Group C:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L;Control Group D:Traditional Chinese Medicine for control group;Control Group D:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L ;Ruijin Hospital affiliated to Shanghai Jiaotong University School of MedicineRecruiting1875BothStudy Group A:55;Study Group A:55;Control group B:55;Control group B:55;Study Group C:45;Study Group C:45;Control Group D:45;Control Group D:45;New Treatment Measure Clinical StudyChina
24NCT02914054October 1, 201616 December 2017Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With DexamethasoneTherapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM)ITP;Croticosteroid TherapyDrug: High dose Dexamethasone pulses;Drug: PrednisoneIsfahan University of Medical SciencesAdibviraNot recruiting18 YearsN/AAll36Phase 2/Phase 3Iran, Islamic Republic of
25NCT03164915September 27, 201611 June 2018A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaBiological: LIV-GAMMA SN Inj.SK Plasma Co., Ltd.Not recruiting19 YearsN/AAll37Phase 3Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2015-003653-17-HU07/09/201628 February 2019An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)Chronic primary immune thrombocytopenia (ITP)
MedDRA version: 19.0 Level: LLT Classification code 10051057 Term: Idiopathic thrombocytopenia System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IgG Next Generation
Product Code: BT595
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Normal Immunoglobulin (iv)
Current Sponsor code: BT595
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Biotest AGNot Recruiting Female: yes
Male: yes
40Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany
27EUCTR2015-003653-17-ES06/09/201628 February 2019An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)Chronic primary immune thrombocytopenia (ITP)
MedDRA version: 19.0 Level: LLT Classification code 10051057 Term: Idiopathic thrombocytopenia System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IgG Next Generation
Product Code: BT595
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Normal Immunoglobulin (iv)
Current Sponsor code: BT595
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Biotest AGNot Recruiting Female: yes
Male: yes
40Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany
28ChiCTR-IIR-160089942016-09-0118 April 2017Safety and efficacy analysis of two conventional dosage regimens Methylprednisone for initial treatment of primary immune thrombocytopenia:A multicenter randomized controlled clinical trialSafety and efficacy analysis of two conventional dosage regimens Methylprednisone for initial treatment of primary immune thrombocytopenia:A multicenter randomized controlled clinical trialPrimary immune thrombocytopeniathe short-course group (Group A):Oral methylprednisolone for 2 weeks, the initial dosage is 0.8mg/kg/d, than reduces to 0.4mg/kg/d for 1 week, than to 0.2mg/kg/d for 1 week, than stop.;the long-course treatment group (Group B):Oral methylprednisolone for 1 month, the initial dosage is 0.8mg/kg/d,than reduces to 0.4mg/kg/d for 1 month, than to 0.1mg/kg/d for 2 week, than stop.;Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical CollegeNot Recruiting1860Boththe short-course group (Group A):150;the long-course treatment group (Group B):150;Phase 4 studyChina
29NCT02298075April 20165 November 2018Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune ThrombocytopeniaResponse Rate and Response Duration After Discontinuation of Treatment With Thrombopoietin Receptor Agonists in Patients Affected by Primary Immune Thrombocytopenia (pITP): Retrospective StudyImmune ThrombocytopeniaDrug: Eltrombopag;Drug: RomiplostinGruppo Italiano Malattie EMatologiche dell'AdultoRecruiting18 YearsN/AAll100Phase 2Italy
30NCT02760251April 201626 August 2019Immunomodulation With Romiplostim in Young Adults With ITPThrombopoietin-receptor Agonist-immunomodulation in Young Adult Primary Immune Thrombocytopenia (ITP): A Multi-center Open Label Trial With RomiplostimImmune ThrombocytopeniaDrug: romiplostimUniversity Hospital, Basel, SwitzerlandUniversity Children's Hospital BaselNot recruiting18 Years45 YearsAll15Phase 4Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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PhaseCountries
31NCT02718716March 20161 April 2019Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune ThrombocytopeniaA Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune ThrombocytopeniaThrombocytopeniaDrug: UCB7665UCB Biopharma S.P.R.L.ParexelNot recruiting18 YearsN/AAll66Phase 2Australia;Bulgaria;Czechia;Georgia;Germany;Italy;Moldova, Republic of;Poland;Romania;Spain;United Kingdom;Belgium;Czech Republic;Lithuania
32EUCTR2015-003984-12-ES29/02/201628 February 2019A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIAPrimary immune thrombocytopenia (ITP)
MedDRA version: 18.1 Level: PT Classification code 10043554 Term: Thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: UCB7665
Product Code: UCB7665
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: UCB7665
CAS Number: 1584645-37-3
Current Sponsor code: UCB7665
Other descriptive name: UCB7665
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
UCB Biopharma SPRLNot Recruiting Female: yes
Male: yes
30Phase 2Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Moldova, Republic of
33EUCTR2015-003984-12-BE22/02/201628 February 2019A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA MedDRA version: 19.1 Level: PT Classification code 10043554 Term: Thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: UCB7665
Product Code: UCB7665
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: UCB7665
CAS Number: 1584645-37-3
Current Sponsor code: UCB7665
Other descriptive name: UCB7665
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
UCB Biopharma SPRLNot Recruiting Female: yes
Male: yes
66Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
34EUCTR2015-003984-12-DE05/02/201628 February 2019A study to test the safety of UCB7665 in patients with low levels of platelets.A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA MedDRA version: 20.0 Level: PT Classification code 10043554 Term: Thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: UCB7665
Product Code: UCB7665
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: UCB7665
CAS Number: 1584645-37-3
Current Sponsor code: UCB7665
Other descriptive name: UCB7665
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
UCB Biopharma SPRLNot Recruiting Female: yes
Male: yes
66Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
35NCT01609452December 201510 August 2015MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITPMONICA-SC: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With Immune Thrombocytopenic Purpura (ITP)Immune Thrombocytopenic Purpura;Idiopathic Thrombocytopenic PurpuraBiological: Blisibimod;Other: PlaceboAnthera PharmaceuticalsNot recruiting18 Years75 YearsBoth0Phase 2/Phase 3
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
36NCT02642380November 20152 May 2016Different 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 TrialImmune ThrombocytopeniaDrug: Dexamethasone (4 cycles);Drug: Dexamethasone (1 cycle)Shandong UniversityNot recruiting18 Years75 YearsBoth0Phase 4China
37JPRN-JapicCTI-15300301/9/20152 April 2019Drug use surveillance of Takecab for Supplement to Helicobacter pylori eradicationDrug use surveillance of Takecab tablets Supplement to Helicobacter pylori eradicationThe following diseases in patients for whom H. pylori will be eradicated with triple therapy: Gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritisIntervention name : Takecab tablets + amoxicillin + clarithromycin (first-line eradication) Takecab tablets + amoxicillin + metronidazole (second-line eradication)
Dosage And administration of the intervention : For adults, the following three-drug regimen will be administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400 mg (potency)/dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful, as an alternative treatment, the following three drugs will be administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants will receive interventions as part of routine medical care.
Control intervention name : null
TAKEDA PHARMACEUTICAL COMPANY LTD.BOTH500NA
38NCT03219723September 1, 201516 December 2017Drug Use Surveillance of Takecab for Supplement to Helicobacter Pylori EradicationDrug Use Surveillance of Takecab Tablets Supplement to Helicobacter Pylori EradicationGastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and OtherDrug: Vonoprazan;Drug: Amoxicillin hydrate;Drug: Clarithromycin;Drug: MetronidazoleTakedaNot recruitingN/AN/AAll500N/AJapan
39NCT02556814September 20152 May 2016Caffeic Acid Combining High-dose Dexamethasone in Management of ITPA Prospective, Multicenter, Placebo Controlled Study on Caffeic Acid Tablet Combining High-dose Dexamethasone in Management of Adult Primary Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaDrug: placebo;Drug: Dexamethasone;Drug: Caffeic acid tabletsShandong UniversityRecruiting18 Years75 YearsBoth240Phase 4China
40NCT02868099September 201516 December 2017Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to Evaluate the Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaDrug: Romiplostim;Drug: PlaceboKyowa Hakko Kirin China Pharmaceutical Co.,LTD.Not recruiting18 YearsN/AAll203Phase 3China
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
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agemin
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agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT02614846August 20157 December 2015Safety and Efficacy Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) PatientsA Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic PurpuraChronic Idiopathic Thrombocytopenic PurpuraDrug: Hetrombopag OlamineJiangsu HengRui Medicine Co., Ltd.Recruiting18 Years65 YearsBoth29Phase 1China
42NCT02402998June 201520 August 2018Eltrombopag in Second Line Adult Primary Immune ThrombosytopeniaEltrombopag as Second Line Therapy in Adult Patients With Primary Immune Thrombocytopenia (ESTIT Study) in an Attempt to Achieve Long-term Remission: a Single Arm Multicenter Phase II Clinical and Biological StudyPrimacy Immune ThrombocytopeniaDrug: EltrombopagGruppo Italiano Malattie EMatologiche dell'AdultoNot recruiting18 YearsN/AAll52Phase 2Italy
43ChiCTR19000212112015-04-014 February 2019A 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, MacauRecruiting18100Both1:60;Pilot studyChina
44NCT02273960November 17, 201429 July 2019Study to Evaluate Safety and Efficacy in Adult Subjects With ITPOpen Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects With Primary Immune Thrombocytopenia (ITP)Immune Thrombocytopenic PurpuraDrug: BMS-986004 75 mg IV;Drug: BMS-986004 225 mg IV;Drug: BMS-986004 675 mg IV;Drug: BMS-986004 1500 mg IVBristol-Myers SquibbNot recruiting18 YearsN/AAll46Phase 1/Phase 2United States;Australia;Canada;Georgia;Moldova, Republic of;Poland;Russian Federation;United Kingdom
45NCT02139501May 20142 May 2016An Investigation of rhTPO With Different Frequencies in the Management of ITPA Randomized Study to Evaluate the Efficacy and Safety of Different Doses and Frequencies of Recombinant Human Thrombopoietin (rhTPO) in the Management of Primary Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaDrug: Recombinant Human Thrombopoietin (rhTPO)Shandong UniversityThe First Affiliated Hospital of Dalian Medical University;Shandong Provincial HospitalNot recruiting18 Years60 YearsBoth48Phase 3China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT02403440April 201413 April 2015A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) PatientsA Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic PurpuraPurpura, Thrombocytopenic, IdiopathicDrug: Hetrombopag OlamineJiangsu HengRui Medicine Co., Ltd.Recruiting18 Years65 YearsBoth24Phase 1China
47NCT01988506January 6, 201427 August 2018Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaRecruiting18 YearsN/AAll132Phase 2France
48EUCTR2013-000961-36-IT22/11/201316 November 2015See the full titleTolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion SpeedPatients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Ig VENA 100 ml vial
Pharmaceutical Form: Solution for infusion
Kedrion SpANot RecruitingFemale: yes
Male: yes
35Phase 3Italy
49EUCTR2013-000961-36-DE15/11/20133 April 2017See the full titleTolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion SpeedPatients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP)
MedDRA version: 16.1 Level: PT Classification code 10054979 Term: Secondary immunodeficiency System Organ Class: 10021428 - Immune system disorders
MedDRA version: 16.1 Level: PT Classification code 10064859 Term: Primary immunodeficiency syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.1 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ig VENA 50 g/l solution for infusion 100 ml vial + infusion setKedrion SpANot RecruitingFemale: yes
Male: yes
35Phase 3Germany;Italy
50EUCTR2013-001371-20-IE06/09/201316 August 2016A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study)Study 200170: A Rollover Study to Provide Continued Treatment with Eltrombopag - Eltrombopag rollover protocolAcute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 14.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864
MedDRA version: 14.1 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB-497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB-497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB-497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: Eltrombopag
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB-497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Product Name: Eltrombopag
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB-497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
GlaxoSmithKline Research and Development LtdNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany;Tunisia;China;Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT01882127February 20132 May 2016All-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 PurpuraDrug: All-Trans Retinoid Acid(ATRA);Drug: DexamethasoneShandong UniversityNot recruiting18 Years75 YearsBoth0Phase 3China
52EUCTR2011-000830-12-NL28/08/201229 January 2018A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicableChronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 16.1 Level: HLGT Classification code 10035534 Term: Platelet disorders System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1 Level: PT Classification code 10043554 Term: Thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1 Level: LLT Classification code 10036735 Term: Primary thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Avatrombopag (proposed)
CAS Number: 1254322-84-3
Current Sponsor code: E5501
Other descriptive name: AKR-501, YM-477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: E5501
Product Code: E5501
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Avatrombopag (proposed)
CAS Number: 1254322-84-3
Current Sponsor code: E5501
Other descriptive name: AKR-501, YM-477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: E5501
Product Code: E5501
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Avatrombopag (proposed)
CAS Number: 1254322-84-3
Current Sponsor code: E5501
Other descriptive name: AKR-501, YM-477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Eisai LimitedNot RecruitingFemale: yes
Male: yes
49Phase 3Czech Republic;Slovakia;Greece;Belgium;Poland;Ukraine;Singapore;Australia;Bulgaria;South Africa;Netherlands;New Zealand
53EUCTR2012-000796-16-DE09/07/20122 September 2013Study to evaluate the efficacy and safety of human immune globulin in patients with primary immune thrombocytopeniaPROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIAPrimary Immune Thrombocytopenia (ITP)
MedDRA version: 14.1 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Octagam 10%
Product Name: Octagam 10%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin
CAS Number: 308067-58-5
Current Sponsor code: Octagam 10%
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-
OCTAPHARMA AGNot RecruitingFemale: yes
Male: yes
30Phase 3Germany;Czech Republic;Poland;Bulgaria
54NCT01734044July 20122 May 2016rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITPA Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)Purpura;Idiopathic Thrombocytopenic PurpuraDrug: recombinant human thrombopoietin (rhTPO); dexamethasone;Drug: DexamethasoneShandong UniversityThe 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 TCMNot recruiting18 Years75 YearsBoth158Phase 3China
55NCT01734057July 20122 May 2016Recombinant 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 PurpuraDrug: recombinant human thrombopoietin (rhTPO); rituximab;Drug: DexamethasoneShandong UniversityThe 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 TCMNot recruiting18 Years75 YearsBoth0Phase 3China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT01433978April 20123 August 2015A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)Idiopathic Thrombocytopenic PurpuraDrug: Eltrombopag;Drug: E5501 - Avatrombopag maleateEisai Inc.Not recruiting18 YearsN/ABoth23Phase 3United States
57EUCTR2011-002184-17-CZ08/02/201214 November 2016Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body.A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITPTo assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period.
MedDRA version: 14.1 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ELTROMBOPAG
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-62-3
Current Sponsor code: SB-497115
Other descriptive name: REVOLADE, PROMACTA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: ELTROMBOPAG
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-62-3
Current Sponsor code: SB-497115
Other descriptive name: REVOLADE, PROMACTA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: ELTROMBOPAG
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-62-3
Current Sponsor code: SB-497115
Other descriptive name: REVOLADE, PROMACTA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: ELTROMBOPAG
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-62-3
Current Sponsor code: SB-497115
Other descriptive name: REVOLADE, PROMACTA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: ELTROMBOPAG
Product Code: SB-497115
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-62-3
Current Sponsor code: SB-497115
Other descriptive name: REVOLADE, PROMACTA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Glaxosmithkline Research and Development LtdNot RecruitingFemale: yes
Male: yes
75Phase 3Germany;Poland;Argentina;Czech Republic;United Kingdom;Italy;Russian Federation;Israel;Chile;Thailand;Spain;Taiwan;Hong Kong;United States
58NCT01444417January 201216 December 2017Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric PatientsA Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenic Purpura;Immune ThrombocytopeniaDrug: Romiplostim;Drug: PlaceboAmgenNot recruiting1 Year17 YearsAll62Phase 3United States;Australia;Canada
59NCT01549054January 201219 February 2015A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy SubjectsIdiopathic Thrombocytopenic PurpuraDrug: 10-mg dose of E5501 2G tablet;Drug: 10-mg dose of E5501 cyclodextrin oral solution;Drug: 10-mg dose of E5501-P21% powder;Drug: 10-mg dose of E5501 lipid-based oralEisai Inc.Not recruiting18 Years55 YearsBoth28Phase 1United Kingdom
60JPRN-JMA-IIA0007031/10/20112 April 2019R-ITP: Clinical Evaluation of Rituximab in Primary Immune ThrombocytopeniaR-ITP: Clinical Evaluation of Rituximab in Primary Immune ThrombocytopeniaIdiopathic Thrombocytopenic PurpuraIntervention type:DRUG. Intervention1:rituximab, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP.Keio University School of Medicine , Yoshitaka miyakawaNot Recruiting>=20 YEARSNo LimitBOTH24Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2011-001354-29-DE12/10/201126 August 2013An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
MedDRA version: 15.1 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
Product Code: I10E
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
Current Sponsor code: I10E
Other descriptive name: human Immunoglobulin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
LFB BIOTECHNOLOGIESNot RecruitingFemale: yes
Male: yes
40France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy
62EUCTR2009-014589-24-DE22/09/20116 October 2015NAProspective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.0 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NewGAM
Product Code: NewGAM
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Immunglobulin
CAS Number: 308067-58-5
Current Sponsor code: NewGam
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-
Octapharma AGNot RecruitingFemale: yes
Male: yes
95Phase 3France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
63NCT01437384September 201119 February 2015Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.An Open-label, Single-sequence, Four-treatment Period Study to Evaluate Pharmacokinetic and Pharmacodynamic Interactions Between E5501 and Verapamil, and E5501 and Cyclosporine, Known P-glycoprotein Inhibitors in Healthy SubjectsIdiopathic Thrombocytopenic Purpura (ITP)Drug: E5501Eisai Inc.Not recruiting18 Years55 YearsBoth36Phase 1United States
64EUCTR2011-000263-27-PL22/07/20113 November 2014An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITPChronic immune thrombocytopenic purpura (ITP)
MedDRA version: 15.0 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Privigen®
Product Name: Privigen®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-
CSL Behring LLCNot RecruitingFemale: yes
Male: yes
150Bulgaria;Turkey;Poland;Serbia
65NCT01525836May 20112 May 2016rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITPRecombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP.Purpura;Idiopathic Thrombocytopenic PurpuraDrug: rituximab; recombinant human thrombopoietin (rhTPO);Drug: RituximabShandong UniversityThe 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 UniversityNot recruiting18 Years72 YearsBoth123Phase 3China
No.TrialIDDate_
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PhaseCountries
66NCT01327872February 201119 February 2015Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy SubjectsA Randomized, Open-Label, 4-Group, 2-Period Replicate Design Study to Evaluate Within- and Between-Subject Variability in Exposure of Two Lots of E5501 20 mg Tablets, Administered as Single Doses of 40 mg, in the Fasted and Fed Conditions to Healthy SubjectsPurpura, Thrombocytopenic, Idiopathic;Acute Idiopathic Thrombocytopenic Purpura;Chronic ThrombocytopeniaDrug: E5501 40 mg 2 x 20-mg tablets, orally, fasted;Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food;Drug: E5501 40mg 2 x 20-mg tablets, orally, fasted;Drug: E5501 40 mg 2 x 20-mg tablets, orally, with foodEisai Inc.Not recruiting18 Years55 YearsBoth84Phase 1Netherlands
67NCT01805648February 201119 February 2015Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITPA Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune ThrombocytopeniaThrombocytopenia;Immune Thrombocytopenia;Idiopathic Thrombocytopenic PurpuraDrug: rhTPOPeking Union Medical CollegeShenyang Sunshine Pharmaceutical Co., LTD.Recruiting14 Years70 YearsBoth120Phase 3China
68NCT01416311December 21, 20104 November 2019Drug Use Investigation for REVOLADE (ITP)Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)Purpura, Thrombocytopaenic, IdiopathicDrug: EltrombopagNovartis PharmaceuticalsNot recruitingN/AN/AAll1000Phase 1/Phase 2
69NCT01143038November 201016 December 2017Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving RomiplostimA Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving RomiplostimIdiopathic Thrombocytopenic PurpuraBiological: RomiplostimAmgenNot recruiting18 YearsN/AAll75Phase 2United States;Australia;Czech Republic;France;Germany;Italy;Poland;Spain;United Kingdom
70NCT01356511September 20102 May 2016High-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 TrialPurpura, Thrombocytopenic, IdiopathicDrug: Prednisone;Drug: DexamethasoneShandong UniversityChinese 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 HospitalNot recruiting18 Years80 YearsBoth261Phase 4China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
71EUCTR2009-010421-39-DE10/03/201010 July 2015A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 15.1 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders
Product Name: Revolade
Product Code: SB497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Product Name: Revolade
Product Code: SB497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Product Name: Revolade
Product Code: SB497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: Revolade
Product Code: SB497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
GlaxoSmithKlineNot RecruitingFemale: yes
Male: yes
200France;Hungary;Czech Republic;Germany;Italy
72EUCTR2009-014842-28-BE06/01/20108 August 2016A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Idiopathic Thrombocytopenic Purpura (ITP).A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Idiopathic Thrombocytopenic Purpura (ITP).Idiopathic Thrombocytopenic Purpura
MedDRA version: 12.0 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Product Name: SM101
Product Code: SM101
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: SM101
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
SuppreMol GmbHNot RecruitingFemale: yes
Male: yes
51Phase 1;Phase 2Poland;Belgium;Germany
73NCT03258866January 1, 201016 December 2017The Study of Different Dose Rituximab in the Treatment of ITPThe Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune ThrombocytopeniaPurpura, Thrombocytopenic, Idiopathic;Immune ThrombocytopeniaDrug: RituximabShandong UniversityNot recruiting10 Years70 YearsAll62Phase 4China
74NCT01071954December 30, 200916 December 2017A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia PurpuraAn Open Label Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITPBiological: RomiplostimAmgenNot recruiting1 YearN/AAll66Phase 3United States;Australia;Canada;Spain
75NCT00908037September 200919 October 2017Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP)A Three Part, Staggered Cohort, Open-label and Double Blind, Randomized, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of Eltrombopag, a Thrombopoietin Receptor Agonist, in Previously Treated Pediatric Patients With Chronic ITP.Purpura, Thrombocytopaenic, IdiopathicDrug: eltrombopag;Drug: PlaceboGlaxoSmithKlineNot recruiting1 Year17 YearsAll82Phase 2United States;Canada;France;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
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agemin
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size
PhaseCountries
76EUCTR2008-001597-33-NL18/06/20093 September 2018Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease. - The TIKI study : Treatment with or without IVIG in Kids with acute ITPDevelopment of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease. - The TIKI study : Treatment with or without IVIG in Kids with acute ITPAcute Idiopathic Thrombocytopenic Purpura (ITP) in children
MedDRA version: 14.1 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: Nanogam
Pharmaceutical Form: Solution for infusion
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
University Medical Center UtrechtNot RecruitingFemale: yes
Male: yes
300Phase 3Netherlands
77EUCTR2008-004347-10-AT17/06/200910 March 2014A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)Thrombocytopenia associated with ITP
MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Romiplostim
Current Sponsor code: AMG 531
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500 deliverable-
Amgen IncNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
78NCT01506414June 20092 May 2016Recombinant 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 PurpuraDrug: rhTPO in combination with RituximabMing HouPeking 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 UniversityNot recruiting16 Years75 YearsBoth91Phase 3China
79NCT00888901May 200919 February 2015Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With EltrombopagAssessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.Idiopathic Thrombocytopenic PurpuraDrug: eltrombopag;Drug: corticosteroids (Aprednislon)Ingrid Pabinger, MDGlaxoSmithKlineNot recruiting18 Years90 YearsBoth30Phase 4Austria
80EUCTR2008-005871-92-SE05/02/200919 March 2012En fas 1 studie av effekt av Tysabri (natalizumab), en IgG4 humaniserad monoklonal antikropp specifik mot VLA-4 (integrin alfa-4), administrerad som infusion 1 gång/månad under 3 månader hos patienter med kronisk idiopatisk trombocytopen purpura (ITP). - Tysabri for ITPEn fas 1 studie av effekt av Tysabri (natalizumab), en IgG4 humaniserad monoklonal antikropp specifik mot VLA-4 (integrin alfa-4), administrerad som infusion 1 gång/månad under 3 månader hos patienter med kronisk idiopatisk trombocytopen purpura (ITP). - Tysabri for ITPChronic idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 9.1 Level: LLT Classification code 10051057 Term: Idiopathic thrombocytopenia
Trade Name: Tysabri
Product Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
Sahlgrenska University HospitalAuthorisedFemale: yes
Male: yes
Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
81NCT00902018January 20091 April 2019Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)The Effect of Eltrombopag on Platelet Survival: the Role of the B-cell L Extra Large (BcL-xL) PathwayImmune ThrombocytopeniaDrug: Eltrombopag;Drug: Romiplostim;Other: healthy controlsWeill Medical College of Cornell UniversityGlaxoSmithKlineNot recruiting18 YearsN/AAll20Phase 2United States
82EUCTR2005-005918-20-FR23/12/200819 March 2012Rituximab as second line treatment for ITP: A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study. “The RITP study” - RITP studyRituximab as second line treatment for ITP: A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study. “The RITP study” - RITP studyImmune thrombocytopenic purpura (ITP)
MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Trade Name: MabThera
Product Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: RITUXIMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
RikshospitaletAuthorisedFemale: yes
Male: yes
110Phase 3United Kingdom;France;Sweden
83EUCTR2004-000172-13-GB20/08/200831 July 2012An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not availableAn Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not availableThrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 8.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AMG 531
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
Amgen Inc.AuthorisedFemale: yes
Male: yes
350Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria
84NCT00749112August 200819 February 2015Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune CytopeniasLow Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune CytopeniasIdiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, AutoimmuneDrug: Alemtuzumab, RituximabHospital Universitario Dr. Jose E. GonzalezNot recruiting16 YearsN/ABoth19Phase 2/Phase 3Mexico
85NCT00511147May 200816 December 2017IGIV Study for Chronic ITP Patients Ages 3-70A Multi-center, Prospective, Open-label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV3I Grifols 10%) in Patients With Idiopathic (Immune) Thrombocytopenic PurpuraIdiopathic Thrombocytopenic PurpuraBiological: IGIV3I Grifols 10%Grifols Biologicals Inc.Instituto Grifols, S.A.Not recruiting3 Years70 YearsAll64Phase 3United States;Canada;India;Puerto Rico
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
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PhaseCountries
86NCT00828750May 200824 September 2018Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)-Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, IdiopathicDrug: Eltrombopag oral tabletsGlaxoSmithKlineNot recruiting20 YearsN/AAll19Phase 3Japan
87EUCTR2007-000638-37-NL28/02/200819 March 2012An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)Immune (Idiopathic) Thrombocytopenic Purpura
MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Product Name: Romiplostim
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Romiplostim
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 600-
Amgen Inc.Not RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
88NCT00571467December 200720 August 2018Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITPAn Open Label, Sequential, Dose Escalation, Repeat-dose Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRTX-100 in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)Idiopathic Thrombocytopenic Purpura (ITP)Drug: PRTX-100 (Staphylococcal protein A)Protalex, Inc.Not recruiting18 YearsN/AAll9Phase 1Australia;New Zealand
89NCT00603642October 1, 200720 May 2019P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic PurpuraIdiopathic Thrombocytopenic PurpuraDrug: Placebo;Drug: AMG 531AmgenNot recruiting20 YearsN/AAll34Phase 3Japan
90EUCTR2007-003569-42-ES29/09/200719 March 2012Estudio Aleatorizado, Doble Ciego, Controlado con Placebo, de Fase 1/2 para Determinar la Seguridad y la Eficacia de AMG 531 en Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) CrónicaEstudio Aleatorizado, Doble Ciego, Controlado con Placebo, de Fase 1/2 para Determinar la Seguridad y la Eficacia de AMG 531 en Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) CrónicaPúrpura Trombocitopénica Inmune (Idiopática) (PTI)
MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Product Name: proteína recombinante estimulante de la megacariopoyesis
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AMG 531
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use
Amgen Inc.AuthorisedFemale: yes
Male: yes
20Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
91NCT00504075September 200719 October 2017A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic PurpuraChronic Idiopathic Thrombocytopenic PurpuraBiological: Gammaplex, intravenous immunoglobulinBio Products LaboratoryNot recruiting18 Years70 YearsAll35Phase 3United States;Argentina;India
92NCT00540423September 200719 October 2017Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) -A Multicenter Study in Subjects With Chronic ITP Receiving a Double-Blind, Placebo-Controlled, Short-Term Treatment Followed by an Open-Label, Uncontrolled, Long-Term Treatment- Chronic Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, IdiopathicDrug: SB-497115-GR 12.5mg;Drug: SB-497115-GR 25mg;Drug: SB-497115-GR 12.5mg matching placebo;Drug: SB-497115-GR 50 mgGlaxoSmithKlineNot recruiting20 YearsN/AAll23Phase 3Japan
93NCT00515203July 200719 October 2017Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric SubjectsA Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic PurpuraIdiopathic Thrombocytopenic Purpura;Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)Drug: Placebo;Drug: AMG 531AmgenNot recruiting1 Year17 YearsAll22Phase 1/Phase 2Australia;Canada;Spain;United States
94NCT00362349June 20078 August 2016Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) PatientsA Single-arm, Open Label, Multi-centre Study Evaluating the Efficacy and Safety of Ig NexGen 10% in Patients With Idiopathic Thrombocytopenic Purpura (ITP)Idiopathic Thrombocytopenic Purpura (ITP)Drug: IgNextGen 10%CSL LimitedNot recruiting18 YearsN/ABoth19Phase 3Australia
95NCT00475423May 200719 October 2017A 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 PurpuraDrug: rituximab [MabThera/Rituxan]Hoffmann-La RocheNot recruiting18 YearsN/AAll122Phase 2Australia
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
96NCT00625443May 200711 June 2018Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003A Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) Who Completed 28 Days of Study Treatment in Protocol 501-CL-003Idiopathic Thrombocytopenic PurpuraDrug: Blinded (placebo);Drug: Open Label (Avatrombopag tablets);Drug: Blinded (Avatrombopoag tablets)Eisai Inc.Not recruiting18 YearsN/AAll53Phase 2United States
97EUCTR2006-002943-10-ES19/04/200719 March 2012REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEATREPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEATIdiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
Pharmaceutical Form: Tablet
INN or Proposed INN: eltrombopag
CAS Number: CASRN496775
Current Sponsor code: SB-497115
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 25-
Product Name: Eltrombopag
Product Code: SB497115
Pharmaceutical Form: Tablet
INN or Proposed INN: eltrombopag
CAS Number: CASRN496775
Current Sponsor code: SB-497115
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
GlaxoSmithKline, S.A.AuthorisedFemale: yes
Male: yes
50Germany;United Kingdom;Spain
98NCT00424177March 200719 October 2017Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT)An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP)Purpura, Thrombocytopaenic, IdiopathicDrug: eltrombopagGlaxoSmithKlineNot recruiting18 YearsN/AAll66Phase 2Germany;Russian Federation;Australia;Canada;India;Korea, Republic of;Netherlands;Spain;Tunisia;United Kingdom;United States
99EUCTR2006-003700-18-AT05/02/200719 March 2012A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraImmune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 8.1 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura
Product Name: AMG 531
Product Code: AMG 531
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: AMG 531
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 600-
Amgen Inc.Not RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
100NCT00441090February 200719 February 2015Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)A Phase 2 Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Parallel Group Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP).Chronic Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, IdiopathicDrug: Placebo;Drug: AKR-501 TabletsEisai Inc.Not recruiting18 YearsN/ABoth64Phase 2United States
No.TrialIDDate_
enrollement
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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size
PhaseCountries
101EUCTR2006-000470-78-FR22/12/200630 April 2019A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEIdiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1 Level: LLT Classification code 10051057 Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
Pharmaceutical Form: Tablet
INN or Proposed INN: eltrombopag
CAS Number: CASRN496775
Current Sponsor code: SB-497115
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Eltrombopag
Product Code: SB497115
Pharmaceutical Form: Tablet
INN or Proposed INN: eltrombopag
CAS Number: CASRN496775
Current Sponsor code: SB-497115
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
GlaxoSmithKline Research and Development LimitedNot Recruiting Female: yes
Male: yes
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
102NCT00415532December 1, 200620 May 2019Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic PurpuraIdiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenic PurpuraDrug: Medical Standard of Care for ITP;Biological: RomiplostimAmgenNot recruiting18 YearsN/AAll234Phase 3Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom;United States
103NCT00392951December 200619 November 2018Sirolimus for Autoimmune Disease of Blood CellsSirolimus for Patients With Chronic and/or Refractory Autoimmune Cytopenias: A Pilot SeriesAutoimmune Pancytopenia;Autoimmune Lymphoproliferative Syndrome (ALPS);Evans Syndrome;Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune;Autoimmune Neutropenia;Lupus Erythematosus, Systemic;Inflammatory Bowel Disease;Rheumatoid ArthritisDrug: sirolimusChildren's Hospital of PhiladelphiaNot recruiting1 Year30 YearsAll30Phase 1/Phase 2United States
104NCT00370331November 200616 December 2017RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With EltrombopagA Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP.Purpura, Thrombocytopaenic, IdiopathicDrug: eltrombopag;Drug: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/AAll197Phase 3United States;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;India;Italy;Netherlands;New Zealand;Peru;Poland;Russian Federation;Slovakia;Spain;Taiwan;Tunisia;Ukraine;United Kingdom;Vietnam;Estonia
105EUCTR2006-000470-78-NL30/10/200618 April 2012A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEA randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEIdiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1 Level: LLT Classification code 10051057 Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
Pharmaceutical Form: Tablet
INN or Proposed INN: eltrombopag
CAS Number: CASRN496775
Current Sponsor code: SB-497115
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Eltrombopag
Product Code: SB497115
Pharmaceutical Form: Tablet
INN or Proposed INN: eltrombopag
CAS Number: CASRN496775
Current Sponsor code: SB-497115
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
GlaxoSmithKline Research and Development LimitedNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
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agemax
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size
PhaseCountries
106EUCTR2006-000471-14-SI13/06/200618 April 2012EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDEXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTENDImmune thrombocytopenic purpura (ITP)Product Name: Eltrombopag
Product Code: SB497115
Pharmaceutical Form: Tablet
INN or Proposed INN: Eltrombopag
CAS Number: CASRN 496775
Current Sponsor code: SB497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Eltrombopag
CAS Number: CASRN 496775
Current Sponsor code: SB497115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
GlaxoSmithKline Research and Development LimitedNot RecruitingFemale: yes
Male: yes
200Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Slovenia;Denmark;Spain;Greece
107NCT00351468June 200616 December 2017EXTEND (Eltrombopag Extended Dosing Study)EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study.Purpura, Thrombocytopaenic, IdiopathicDrug: eltrombopag olamine (SB-497115-GR)Novartis PharmaceuticalsNot recruiting18 YearsN/AAll302Phase 3United States;Australia;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Italy;Korea, Republic of;Netherlands;New Zealand;Pakistan;Peru;Poland;Romania;Russian Federation;Slovakia;Slovenia;Spain;Sweden;Taiwan;Thailand;Tunisia;Ukraine;United Kingdom;Vietnam;India;Ireland;Mexico;Norway
108NCT00426270June 200619 October 2017Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in AdultsClinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in AdultsImmune Thrombocytopenic PurpuraDrug: Octagam 10%OctapharmaNot recruiting18 YearsN/AAll116Phase 3Austria
109EUCTR2005-003552-35-DE28/03/200619 March 2012Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/AClinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/AIdiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.
MedDRA version: 7.0 Level: LLT Classification code 10021245
Product Name: Octagam® 10%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Immunoglobulin G
Current Sponsor code: GAM10
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-
Octapharma AGNot RecruitingFemale: yes
Male: yes
116Czech Republic;Germany;France
110NCT00467571March 200619 February 2015Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic PurpuraHelicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic PurpuraChronic Idiopathic Thrombocytopenic Purpura;Helicobacter Pylori InfectionDrug: lansoprazole, clarithromycin, amoxycillinMahidol UniversityRamathibodi HospitalNot recruiting2 Years18 YearsBoth26Phase 4Thailand
No.TrialIDDate_
enrollement
Last_Refreshed_
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Status
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PhaseCountries
111NCT00451594September 200519 February 2015High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITPA Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic PurpuraIdiopathic Thrombocytopenic PurpuraDrug: Dexamethasone;Drug: PrednisoloneCooperative Study Group A for HematologyNot recruiting16 YearsN/ABoth157Phase 3Korea, Republic of
112NCT00244257August 200520 April 2015Safety Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)Phase I, Open-Label, Multi-center, Single-Dose, Dose-Escalating, Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamic Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)Idiopathic Thrombocytopenic PurpuraBiological: GMA161Genzyme, a Sanofi CompanyNot recruiting18 YearsN/ABoth10Phase 1United States
113NCT00770562July 200519 October 2017A 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 PurpuraIdiopathic Thrombocytopenic PurpuraDrug: rituximab;Drug: DexamethasoneHoffmann-La RocheNot recruiting18 YearsN/AAll103Phase 3Italy
114EUCTR2005-000859-15-IT14/04/200519 March 2012Randomized 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
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Rituximab
CAS Number: 174722-31-7
Current Sponsor code: RO 29-9800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
ROCHENot RecruitingFemale: yes
Male: yes
Italy
115NCT00102336April 7, 200520 May 2019AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to SplenectomyA Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to SplenectomyThrombocytopenia;Idiopathic Thrombocytopenic PurpuraBiological: AMG 531;Drug: PlaceboAmgenNot recruiting18 YearsN/AAll62Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
116NCT00102323March 29, 200520 May 2019AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to SplenectomyA Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to SplenectomyThrombocytopenia;Idiopathic Thrombocytopenic PurpuraDrug: Placebo;Biological: AMG 531AmgenNot recruiting18 YearsN/AAll63Phase 3France;Netherlands;Spain;United States
117NCT00508820February 1, 200520 May 2019An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITPAn Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenic PurpuraBiological: RomiplostimAmgenNot recruiting18 YearsN/AAll407Phase 3Australia;Austria;Belgium;Canada;Czech Republic;Ireland;Italy;Netherlands;Poland;Slovakia;Spain;Switzerland;United Kingdom;United States
118NCT00128882November 200419 February 2015Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-DTreatment of Idiopathic Thrombocytopenic Purpura in Children With Subcutaneously Administered Anti-DIdiopathic Thrombocytopenic PurpuraDrug: Anti-DUniversity of AarhusKjaersgaard, Mimi, M.D.Not recruiting1 Year14 YearsBoth45Phase 2Denmark
119NCT01713855October 200419 February 2015Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic PurpuraVaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)Idiopathic Thrombocytopenic Purpura;Immune Thrombocytopenic PurpuraBiological: Inactivated Trivalent Influenza vaccineNeufeld, Ellis J, MD, PhDTerrana ITP Research FundNot recruiting18 Months18 YearsBoth10N/AUnited States
120NCT00116688August 200419 October 2017Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)Thrombocytopenia;Idiopathic Thrombocytopenic PurpuraBiological: RomiplostimAmgenNot recruiting1 YearN/AAll313Phase 3Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom;United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
121NCT00909077August 200430 September 2019The 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 PurpuraDrug: Dexamethasone;Drug: Dexamethasone and RituximabCopenhagen University Hospital at HerlevNot recruiting18 YearsN/AAll155Phase 3Denmark
122NCT00161564February 200423 July 2018A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan AloneA 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 TreatmentIdiopathic Thrombocytopenic Purpura (ITP)Drug: RituximabWeill Medical College of Cornell UniversityGenentech, Inc.Not recruiting12 YearsN/AAll0Phase 2United States
123NCT00111475June 200319 February 2015Evaluating the Safety and Efficacy of AMG531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura(ITP)A Dose-Finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)Idiopathic Thrombocytopenic PurpuraDrug: AMG 531AmgenNot recruiting18 Years65 YearsBothPhase 2
124NCT01713738May 200319 February 2015Clinical 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 AdolescentsIdiopathic Thrombocytopenic Purpura (ITP);Immune Thrombocytopenic Purpura (ITP)Drug: rituximabNeufeld, Ellis J, MD, PhDGenentech, Inc.;Biogen Idec;Glaser Pediatric Research Network;Terrana ITP Research FundNot recruiting18 Months18 YearsBoth36Phase 1/Phase 2United States
125NCT00162006January 1, 200329 January 2018Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic PurpuraProspective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic PurpuraImmune Thrombocytopenic Purpura (ITP)Drug: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced SolutionBaxalta now part of ShireNot recruiting18 Years65 YearsAll28Phase 2Czechia;Germany;Hungary;Poland;Czech Republic
No.TrialIDDate_
enrollement
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on
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agemin
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agemax
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PhaseCountries
126NCT00151840October 200119 February 2015Efficacy and Safety of IVIG-L in ITP PatientsEfficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)PatientsPurpura, Thrombocytopenic, IdiopathicDrug: IVIG-LSanquinNot recruiting18 YearsN/ABoth20Phase 3Poland
127NCT00107913September 200119 February 2015Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic PurpuraPhase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic PurpuraAutoimmune Thrombocytopenic PurpuraDrug: DoxilHematology and Oncology SpecialistsRecruitingN/AN/ABoth10Phase 2United States

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