63. 特発性血小板減少性紫斑病
[臨床試験数:311,薬物数:185(DrugBank:39),標的遺伝子数:43,標的パスウェイ数:132

Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
284 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002101-21-GB
(EUCTR)
16/12/202029/10/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
2EUCTR2019-002101-21-DE
(EUCTR)
15/12/202026/10/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
3NCT04596995
(ClinicalTrials.gov)
December 202015/10/2020A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)Primary Immune ThrombocytopeniaDrug: RozanolixizumabUCB Biopharma SRLNULLNot yet recruiting18 YearsN/AAll210Phase 3NULL
4EUCTR2019-004103-12-DE
(EUCTR)
27/11/202002/04/2020A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune ThrombocytopeniaA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: TAK-079
Product Code: TAK-079
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Millennium Pharmaceuticals, Inc. (Takeda)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Slovenia;Ukraine;Croatia;Germany
5EUCTR2020-003232-24-HU
(EUCTR)
11/11/202020/10/2020Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune ThrombocytopeniaA Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment
MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Doptelet 20 mg film-coated tablets
Product Name: avatrombopag
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AVATROMBOPAG MALEATE
Dova Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 3United States;France;Czech Republic;Hungary;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04278924
(ClinicalTrials.gov)
November 9, 202019/2/2020Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Participants With Persistent/Chronic Primary Immune ThrombocytopeniaA Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Persistent/Chronic Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaDrug: Placebo;Drug: TAK-079Millennium Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll54Phase 2United States;Bulgaria;Croatia;Germany;Italy;Slovenia;Ukraine
7EUCTR2019-000883-40-GB
(EUCTR)
29/10/202011/09/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China
8EUCTR2019-004683-22-NO
(EUCTR)
16/10/202029/04/2020Daratumumab as a treatment for adult immune thrombocytopeniaDaratumumab as a treatment for adult immune thrombocytopenia - The DART-study Immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: daratumumab
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Ostfold Hospital TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Norway
9EUCTR2019-000883-40-PL
(EUCTR)
09/10/202025/08/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China
10EUCTR2019-000883-40-CZ
(EUCTR)
05/10/202012/08/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-000883-40-HU
(EUCTR)
29/09/202011/08/2020A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP)An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: Rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan
12EUCTR2019-004103-12-HR
(EUCTR)
25/09/202023/11/2020A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune ThrombocytopeniaA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: TAK-079
Product Code: TAK-079
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Millennium Pharmaceuticals, Inc. (Takeda)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Slovenia;Ukraine;Croatia
13EUCTR2019-004103-12-SI
(EUCTR)
16/09/202028/04/2020A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune ThrombocytopeniaA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: TAK-079
Product Code: TAK-079
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Millennium Pharmaceuticals, Inc. (Takeda)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Slovenia;Ukraine
14ChiCTR2000035408
2020-08-202020-08-10A randomized controlled study for rituximab in first-line treatment of newly diagnosed immune thrombocytopeniaStudy of rituximab in first-line treatment of newly diagnosed immune thrombocytopenia Idiopathic Thrombocytopenic PurpuraStandard dose group:Rituximab (Hanrikang) 375mg/m2, 4 times a week (day 8, 15, 22, 29).;Low-dose group:Rituximab (Hanrikang) 100mg/ time once a week, administered 4 times (day 8, 15, 22 and 29).;Dexamethasone control group:high-dose dexamethasone (HD-DXM), 40mg/d, iv for 4 days (day 1 to day 4), every 15 days, 2 to 4 cycles, until CR or the end of the study.;Henan Cancer HospitalNULLRecruiting1865BothStandard dose group:20;Low-dose group:20;Dexamethasone control group:20;Phase 4China
15EUCTR2019-003451-11-DE
(EUCTR)
17/08/202014/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04428255
(ClinicalTrials.gov)
July 21, 20209/6/2020A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITPA Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Designed Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Weekly Subcutaneous Injection in Patients With Primary Immune ThrombocytopeniaPrimary Immune Thrombocytopenic PurpuraDrug: HBM9161 Dose A;Drug: HBM9161 Dose B;Drug: PlaceboHarbour BioMed (Guangzhou) Co. Ltd.NULLNot yet recruiting18 YearsN/AAll36Phase 2;Phase 3China
17EUCTR2019-003451-11-AT
(EUCTR)
13/07/202028/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan
18JPRN-JapicCTI-205351
13/7/202001/07/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) Primary immune thrombocytopeniaIntervention name : Rozanolixizumab
INN of the intervention : rozanolixizumab
Dosage And administration of the intervention : Study participants receive rozanolixizumab by subcutaneous infusion at pre-specified time points.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : -
UCB Japan Co., Ltd.NULLpending18BOTH10Phase 3Japan, Asia except Japan, North America, Europe
19EUCTR2019-000884-26-AT
(EUCTR)
06/07/202028/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Japan
20NCT04274452
(ClinicalTrials.gov)
June 29, 202014/2/2020A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia (ITP)Primary Immune Thrombocytopenia (ITP)Biological: efgartigimod;Other: PlaceboargenxNULLWithdrawn18 YearsN/AAll0Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04224688
(ClinicalTrials.gov)
June 3, 20208/1/2020A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)Primary Immune ThrombocytopeniaDrug: Rozanolixizumab;Other: PlaceboUCB Biopharma SRLNULLRecruiting18 YearsN/AAll105Phase 3United States;Bulgaria;Canada;France;Germany;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom
22NCT04225156
(ClinicalTrials.gov)
June 2, 20206/1/2020A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia.Primary Immune ThrombocytopeniaBiological: efgartigimodargenxNULLRecruiting18 YearsN/AAll156Phase 3United States;Belgium;Bulgaria;Czechia;France;Hungary;Italy;Japan;Netherlands;Russian Federation;Spain;Ukraine
23EUCTR2019-002101-21-NL
(EUCTR)
25/05/202007/01/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany;Japan
24EUCTR2019-003451-11-NL
(EUCTR)
22/05/202003/03/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan
25EUCTR2019-000884-26-FR
(EUCTR)
11/05/202026/05/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2019-002101-21-BG
(EUCTR)
08/05/202024/04/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
27EUCTR2019-002101-21-CZ
(EUCTR)
06/05/202010/03/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
28ChiCTR2000030603
2020-05-012020-03-08Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopeniaClinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia Primary Immune ThrombocytopeniaThe short -course glucocorticoid group:treat with glucocorticoid;The eltrombopag group:treat with eltrombopag;The rituximab group:treat with rituximab;Splenectomy group:treat with splenectomy;The azathioprine group:treat with azathioprine;The cyclosporine group:treat with cyclosporine;The Second Affiliated Hospital of Kunming Medical UniversityNULLPending1875BothThe short -course glucocorticoid group:65;The eltrombopag group:65;The rituximab group:65;Splenectomy group:65;The azathioprine group:65;The cyclosporine group:65;Phase 4China
29EUCTR2019-003451-11-BG
(EUCTR)
30/04/202004/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan
30EUCTR2019-000884-26-BG
(EUCTR)
30/04/202004/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2019-002100-41-AT
(EUCTR)
30/04/202025/11/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
32EUCTR2019-002101-21-BE
(EUCTR)
28/04/202003/03/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
33EUCTR2019-000884-26-CZ
(EUCTR)
23/04/202025/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Japan
34EUCTR2019-003451-11-ES
(EUCTR)
22/04/202028/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan
35EUCTR2019-000884-26-ES
(EUCTR)
22/04/202028/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2019-002101-21-FR
(EUCTR)
22/04/202020/02/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan
37EUCTR2019-000884-26-GB
(EUCTR)
20/04/202016/03/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Japan
38EUCTR2019-002100-41-DE
(EUCTR)
14/04/202025/11/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
39EUCTR2019-000884-26-HU
(EUCTR)
13/04/202011/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Georgia;Bulgaria;Germany;Japan;United States;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania
40EUCTR2019-002101-21-ES
(EUCTR)
09/04/202023/01/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2019-002101-21-HU
(EUCTR)
07/04/202031/01/2020A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
42EUCTR2019-003451-11-PL
(EUCTR)
25/03/202011/02/2020A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan
43EUCTR2019-000884-26-PL
(EUCTR)
20/03/202003/02/2020A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 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: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Hong Kong;Taiwan;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of;Japan;China
44NCT03692754
(ClinicalTrials.gov)
March 1, 202029/9/2018Atorvastatin 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 UniversityNULLRecruiting18 Years80 YearsAll30Phase 4China
45EUCTR2019-002100-41-PL
(EUCTR)
10/02/202013/11/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT04200456
(ClinicalTrials.gov)
January 31, 202013/12/2019A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)Primary Immune ThrombocytopeniaDrug: Rozanolixizumab;Other: PlaceboUCB Biopharma SRLNULLRecruiting18 YearsN/AAll105Phase 3United States;Belgium;Bulgaria;France;Georgia;Hungary;Italy;Japan;Moldova, Republic of;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom
47EUCTR2019-002100-41-GB
(EUCTR)
10/01/202005/08/2020A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
48EUCTR2019-002100-41-BE
(EUCTR)
10/01/202021/11/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
49ChiCTR1900027735
2020-01-012019-11-24Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP)Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP) Adult newly diagnosed immune thrombocytopeniaStudy group:Dexamethasone 40mg/d×4d, recombinant human thrombopoietin (rhTPO) 300U/Kg subcutaneous injection, once/d×14d, if PLT>100×109/L or PLT increase =50×109/L during treatment period RhTPO drug was discontinued; rhTPO and dexamethasone were replaced with prednisone 0.5mg~1mg/kg once a day, 0.2mg/kg per week, and the drug was stopped wit;Control group:Dexamethasone 40mg/d×4d, if the PLT>100×10^9/L or PLT increase =50×10^9/L during the treatment period, dexamethasone was replaced with prednisone 0.5mg~ 1mg/kg orally every day, reduce 0.2mg/kg per week, and quickly reduce the dose within 6~8 weeks.;Department of Hematology, Anhui Provincial HospitalNULLPending1880BothStudy group:30;Control group:30;Phase 4China
50NCT04214951
(ClinicalTrials.gov)
January 1, 202028/12/2019A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune ThrombocytopeniaA Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune ThrombocytopeniaCorticosteroid-resistant or Relapsed ITPDrug: Eltrombopag;Drug: Recombinant human thrombopoietin (rh-TPO)Peking University People's HospitalNULLActive, not recruiting18 Years75 YearsAll100China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT04132050
(ClinicalTrials.gov)
December 24, 201915/10/2019A 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.NULLRecruiting20 YearsN/AAll24Phase 3Japan
52EUCTR2019-002100-41-HU
(EUCTR)
17/12/201930/10/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
53EUCTR2019-002100-41-ES
(EUCTR)
16/12/201911/11/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
54NCT04188379
(ClinicalTrials.gov)
December 16, 20194/12/2019A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia (ITP)Primary Immune ThrombocytopeniaBiological: efgartigimod;Other: PlaceboargenxNULLRecruiting18 YearsN/AAll156Phase 3United States;Austria;Belgium;Bulgaria;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
55ChiCTR1900027748
2019-12-012019-11-25Clinical study of rituximab in the treatment of refractory immune thrombocytopeniaClinical study of rituximab in the treatment of refractory immune thrombocytopenia Primary Immune ThrombocytopeniaCase series:Treating with rituximab (hanlikan);Department of Hematology, the Second Affiliated Hospital of Kunming Medical UniversityNULLPendingBothCase series:60;Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56ChiCTR1900027753
2019-12-012019-11-25Efficacy and safety of cyclosporine and azathioprine in patients with refractory ITPEfficacy and safety of cyclosporine and azathioprine in patients with refractory ITP Primary Immune ThrombocytopeniaGroup 1:Using cyclosporine A for treatment;Group 2:Using azathioprine for treatment;Control group:Treatment with glucocorticoids;the Second Affiliated Hospital of Kunming Medical UniversityNULLPending1875BothGroup 1:30;Group 2:30;Control group:30;N/AChina
57EUCTR2019-002100-41-NL
(EUCTR)
01/11/201907/08/2019A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia Primary immune thrombocytopenia
MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
argenx BVBANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
156Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
58NCT04113915
(ClinicalTrials.gov)
November 20191/10/2019Viral 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 KhaledNULLNot yet recruiting18 Years75 YearsAll150NULL
59JPRN-jRCTs041190069
01/10/201925/09/2019Clinical 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 ITP Chronic Idiopathic Thrombocytopenic Purpura
refractory, immune, thrombocytopenia,;D016553
Administration of dexamethasone palmitate (5mg/day for 4 days)Nakayama TakayukiNULLRecruiting>= 20age old<= 75age oldBoth7Phase 1Japan
60NCT03998982
(ClinicalTrials.gov)
June 25, 201925/6/2019Glycyrrhetinic 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 UniversityNULLRecruiting18 Years80 YearsAll30Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2019-000361-21-GB
(EUCTR)
30/04/201906/02/2020A Multicenter, Open-Label, Phase 2 Trial to Evaluate the Safety and Activity of Efgartigimod (ARGX-113) in Adult Patients with Primary Immune Thrombocytopenia - ARGX-113-1804A Multicenter, Open-Label, Phase 2 Trial to Evaluate the Safety and Activity of Efgartigimod (ARGX-113) in Adult Patients with Primary Immune Thrombocytopenia - ARGX-113-1804 Primary 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: efgartigimod
Product Code: ARGX-113
Other descriptive name: ARGX-113
Product Name: efgartigimod
Product Code: ARGX-113
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
15Phase 2Hungary;Spain;Ukraine;United Kingdom
62NCT03412188
(ClinicalTrials.gov)
August 1, 201820/1/2018The 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 ElsherifNULLRecruiting1 Year18 YearsAll40N/AEgypt
63NCT03830749
(ClinicalTrials.gov)
July 1, 20181/2/2019Safety 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 LimitedNULLRecruiting18 YearsN/AAll60Phase 2Hong Kong
64ChiCTR1800016177
2018-07-012018-05-16Efficacy and safety of danazol combined with low-dose glucocorticoids in the treatment of refractory/recurrent primary immune thrombocytopenia: a multicenter, single arm, prospective and open clinical studyEfficacy and safety of danazol combined with low-dose glucocorticoids in the treatment of refractory/recurrent primary immune thrombocytopenia: a multicenter, single arm, prospective and open clinical study prospective and open clinical study Immune thrombocytopenic purpuraexperimental group:danazol combined with low-dose glucocorticoids ;Second Affiliated Hospital of Dalian Medical UniversityNULLRecruiting4090Femaleexperimental group:30;N/AChina
65EUCTR2015-003653-17-CZ
(EUCTR)
07/05/201809/09/2016An 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]
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40Phase 3Hungary;Czech Republic;Spain;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66ChiCTR-OON-17014165
2018-01-012017-12-27A 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 thrombocytopenia Immune Thrombocytopeniaone:Corticosteroids;two:Corticosteroids combined with Cyclosporin A ;Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyNULLRecruiting1865Bothone:100;two:100;China
67ChiCTR-ONC-17012126
2017-09-012017-07-25A 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 thrombocytopenia refractory or recurrence primary immune thrombocytopeniaCase series:Sirolimus treats refractory or recurrence primary immune thrombocytopenia;Department of Hematology, Xiniao HospitalNULLPending1880BothCase series:103;China
68EUCTR2015-003984-12-BG
(EUCTR)
15/08/201702/06/2017A 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
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
69NCT03275740
(ClinicalTrials.gov)
July 17, 20176/7/2017A 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 AND SUBCUTANEOUS DOSING TO HEALTHY ADULT MALE PARTICIPANTSPolyradiculoneuropathy, Chronic Inflammatory Demyelinating;Primary Immune ThrombocytopeniaDrug: PF-06755347 intravenous;Drug: Placebo intravenous;Drug: PF-06755347 subcutaneous;Drug: Placebo subcutaneousPfizerNULLRecruiting18 Years55 YearsMale84Phase 1United States;Belgium;New Zealand;United Kingdom
70EUCTR2015-003984-12-LT
(EUCTR)
14/07/201702/05/2017A 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]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
66Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT03222843
(ClinicalTrials.gov)
June 30, 201718/7/2017Multicentre, 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.NULLRecruiting18 YearsN/AAll414Phase 3China
72ChiCTR-ONC-17013230
2017-05-202017-11-03A 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 thrombocytopenia primary immune thrombocytopeniaCase series:PKA agonist (aminophylline) treats chronic or refractory primary immune thrombocytopenia;Department of Hematology, The First Affiliated Hospital of Soochow UniversityNULLCompleted1165BothCase series:60;China
73EUCTR2016-003038-26-DE
(EUCTR)
27/04/201708/12/2016A 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 Primary 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]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36Phase 2France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
74EUCTR2016-003038-26-CZ
(EUCTR)
10/02/201702/12/2016A 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 Primary 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]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36Phase 2France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
75EUCTR2016-003038-26-GB
(EUCTR)
08/02/201716/11/2016A 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 BVBA Primary 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
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
36Phase 2France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Austria;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2016-003038-26-ES
(EUCTR)
07/02/201727/12/2016A 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 Primary Immune Thrombocytopenia
MedDRA version: 19.0;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36Phase 2France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
77EUCTR2016-003038-26-AT
(EUCTR)
06/02/201714/12/2016A 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 Primary 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]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36Phase 2France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
78EUCTR2015-003653-17-BG
(EUCTR)
27/01/201721/11/2016An 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]
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany
79EUCTR2016-003038-26-BE
(EUCTR)
27/01/201708/12/2016A 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. Primary 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
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
36Phase 2France;Hungary;Czech Republic;Poland;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom
80EUCTR2015-003653-17-DE
(EUCTR)
27/01/201717/06/2016An 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]
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2016-003038-26-HU
(EUCTR)
19/01/201730/11/2016A 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 Primary Immune Thrombocytopenia
MedDRA version: 19.0;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Argenx BVBANULLNot Recruiting Female: yes
Male: yes
36Phase 2France;Czech Republic;Hungary;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
82EUCTR2015-005276-14-DK
(EUCTR)
08/12/201619/10/2016Maintenance 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-trial Immune thrombocytopenia
MedDRA version: 20.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Sykehuset Østfold HFNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100Phase 3France;United States;Denmark;Norway;Tunisia;United Kingdom
83NCT04089267
(ClinicalTrials.gov)
December 201610/9/2019Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)ITPDrug: TPOShenyang Sunshine Pharmaceutical Co., LTD.NULLCompleted18 YearsN/AAll288Phase 4China
84ChiCTR-INR-16009363
2016-10-132016-10-10'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 thrombocytopenia Immune 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 MedicineNULLRecruiting1875BothStudy 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;China
85NCT03164915
(ClinicalTrials.gov)
September 27, 201622/5/2017A 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.NULLUnknown status19 YearsN/AAll37Phase 3Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2015-003653-17-HU
(EUCTR)
07/09/201619/07/2016An 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]
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany
87EUCTR2015-003653-17-ES
(EUCTR)
06/09/201611/08/2016An 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]
Biotest AGNULLNot Recruiting Female: yes
Male: yes
40Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany
88ChiCTR-IIR-16008994
2016-09-012016-08-08Safety 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 trial Primary 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 CollegeNULLPending1860Boththe short-course group (Group A):150;the long-course treatment group (Group B):150;4 (Phase 4 study)China
89EUCTR2015-003984-12-PL
(EUCTR)
09/06/201606/04/2016A 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]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
132Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Poland;Belgium;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
90EUCTR2015-003984-12-IT
(EUCTR)
11/04/201605/11/2020A 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 - - Primary immune thrombocytopenia (ITP)
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 ]
INN or Proposed INN: UCB7665
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Czechia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT02298075
(ClinicalTrials.gov)
April 201617/11/2014Response 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'AdultoNULLUnknown status18 YearsN/AAll100Italy
92EUCTR2015-003984-12-CZ
(EUCTR)
16/03/201622/12/2015A 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]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
66Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
93EUCTR2015-003984-12-ES
(EUCTR)
29/02/201613/01/2016A 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 Primary 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]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
30Phase 2Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Moldova, Republic of
94EUCTR2015-003984-12-BE
(EUCTR)
22/02/201615/01/2016A 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]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
66Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
95EUCTR2015-003984-12-DE
(EUCTR)
05/02/201623/11/2015A 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]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
66Phase 2Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2014-001429-33-PL
(EUCTR)
07/12/201509/10/2015Study to evaluate safety and efficacy in adult subjects with ITPOpen Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacyof BMS-986004 in Adult Subjects with Primary Immune Thrombocytopenia (ITP) Immune Thrombocytopenia
MedDRA version: 19.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anti-CD40LdAb
Product Code: BMS-986004
INN or Proposed INN: N/A
Other descriptive name: anti-CD40L
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Canada;Poland;Australia;Russian Federation;Georgia;Moldova, Republic of
97NCT01609452
(ClinicalTrials.gov)
December 201523/5/2012MONICA-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 PharmaceuticalsNULLWithdrawn18 Years75 YearsBoth0Phase 2;Phase 3NULL
98NCT02642380
(ClinicalTrials.gov)
November 201524/12/2015Different 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 UniversityNULLWithdrawn18 Years75 YearsBoth0Phase 4China
99JPRN-JapicCTI-153003
01/9/2015Drug use surveillance of Takecab for Supplement to Helicobacter pylori eradicationDrug use surveillance of Takecab tablets Supplement to Helicobacter pylori eradication The 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.NULLBOTH500NANULL
100NCT03219723
(ClinicalTrials.gov)
September 1, 20159/7/2017Drug 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: MetronidazoleTakedaNULLCompletedN/AN/AAll560Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT02556814
(ClinicalTrials.gov)
September 201521/9/2015Caffeic 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: Caffeic acid tablets;Drug: Dexamethasone;Drug: placeboShandong UniversityNULLCompleted18 Years75 YearsAll214Phase 4China
102NCT02868099
(ClinicalTrials.gov)
September 201511/8/2016Efficacy 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.NULLCompleted18 YearsN/AAll203Phase 3China
103NCT02614846
(ClinicalTrials.gov)
August 201519/11/2015Safety 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.NULLRecruiting18 Years65 YearsBoth29Phase 1China
104EUCTR2015-001327-23-IT
(EUCTR)
26/06/201529/04/2015Study about the effect of a drug (Eltrombopag)which is administered in patients with thrombocytopenia primary Immune, a relative decrease of platelets in blood (small blood components that help the clotting process by sticking to the lining of blood vessels).Eltrombopag 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 study Primary Immune Thrombocytopenia
MedDRA version: 18.0;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]
Trade Name: Revolade
Product Name: Revolade
INN or Proposed INN: NA
Other descriptive name: ELTROMBOPAG OLAMINE
Trade Name: Revolade
Product Name: Revolade
INN or Proposed INN: NA
Other descriptive name: ELTROMBOPAG OLAMINE
Fondazione G.I.M.EM.A. Gruppo Italiano Malattie Ematologiche dell'AdultoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 2Italy
105NCT02402998
(ClinicalTrials.gov)
June 201522/3/2015Eltrombopag 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'AdultoNULLUnknown status18 YearsN/AAll52Phase 2Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106ChiCTR1900021211
2015-04-012019-02-01A 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, MacauNULLRecruiting18100Both1:60;China
107EUCTR2014-001429-33-GB
(EUCTR)
24/11/201407/10/2014Study to evaluate safety and efficacy in adult subjects with ITP Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects with Primary Immune Thrombocytopenia (ITP) Immune Thrombocytopenia
MedDRA version: 19.0;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
80Phase 2United States;Canada;Poland;United Kingdom
108NCT02273960
(ClinicalTrials.gov)
November 17, 20143/10/2014Study 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 SquibbNULLCompleted18 YearsN/AAll46Phase 1;Phase 2United States;Australia;Canada;Georgia;Moldova, Republic of;Poland;Russian Federation;United Kingdom
109EUCTR2013-001371-20-NL
(EUCTR)
06/05/201419/03/2014A 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 ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
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] - Cancer [C04]
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of
110EUCTR2013-001371-20-PL
(EUCTR)
11/04/201424/02/2014A 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 ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
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] - Cancer [C04]
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
100United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT02403440
(ClinicalTrials.gov)
April 201420/3/2015A 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.NULLRecruiting18 Years65 YearsBoth24Phase 1China
112EUCTR2013-001371-20-GR
(EUCTR)
10/12/201311/11/2013A 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 ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
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] - Cancer [C04]
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Tunisia;Netherlands;Germany;China;Korea, Republic of
113EUCTR2013-000961-36-IT
(EUCTR)
22/11/201321/08/2013See the full titleTolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed Patients 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
Product Name: Ig VENA
Kedrion SpANULLNot RecruitingFemale: yes
Male: yes
35Phase 3Italy
114EUCTR2013-000961-36-DE
(EUCTR)
15/11/201305/08/2013See the full titleTolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed Patients 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;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.1;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 SpANULLNot RecruitingFemale: yes
Male: yes
35Phase 3Germany;Italy
115EUCTR2013-001371-20-BE
(EUCTR)
15/10/201310/09/2013A 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 ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 17.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
MedDRA version: 17.0;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Relovade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Relovade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Tunisia;Germany;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2013-001371-20-ES
(EUCTR)
15/10/201308/08/2013A 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 ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP
MedDRA version: 16.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864
MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Relovade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Relovade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline, S.A.NULLNot 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
117EUCTR2013-001371-20-IE
(EUCTR)
06/09/201311/07/2013A 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 ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol Acute 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
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research and Development LtdNULLNot 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
118EUCTR2010-019987-35-FR
(EUCTR)
26/06/201309/09/2010A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostimA Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostim Adult immune thrombocytopenic purpura (ITP)
MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Trade Name: Nplate
Product Name: romiplostim
Product Code: AMG 531
INN or Proposed INN: romiplostim
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2France;Czech Republic;Spain;Germany;United Kingdom;Italy
119EUCTR2009-014589-24-FR
(EUCTR)
12/06/201327/09/2011NAProspective, 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-02 Primary Immune Thrombocytopenia (ITP)
MedDRA version: 14.0;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
Other descriptive name: IMMUNOGLOBULIN G
Octapharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
95Phase 3France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
120NCT01882127
(ClinicalTrials.gov)
February 201319/4/2013All-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 UniversityNULLWithdrawn18 Years75 YearsBoth0Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2011-000830-12-GR
(EUCTR)
16/11/201208/10/2012A 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 applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 15.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 15.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;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
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hong Kong;Slovakia;Greece;Ukraine;Czech Republic;Poland;Belgium;Singapore;Romania;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
122EUCTR2011-001354-29-ES
(EUCTR)
24/09/201219/07/2012An 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: 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]
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy
123EUCTR2011-000830-12-NL
(EUCTR)
28/08/201223/08/2011A 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 applicable Chronic 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;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;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
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Czech Republic;Slovakia;Greece;Belgium;Poland;Ukraine;Singapore;Australia;Bulgaria;South Africa;Netherlands;New Zealand
124EUCTR2012-000796-16-PL
(EUCTR)
17/08/201225/06/2012Study to evaluate the efficacy and safety of human immuneglobulin 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 THROMBOCYTOPENIA Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Czech Republic;Poland;Bulgaria
125EUCTR2012-000796-16-BG
(EUCTR)
18/07/201222/05/2012Study to evaluate the efficacy and safety of human immuneglobulin 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 THROMBOCYTOPENIA Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Czech Republic;Poland;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2011-000831-10-DE
(EUCTR)
18/07/201216/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
127EUCTR2011-000831-10-BE
(EUCTR)
16/07/201215/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
128EUCTR2012-000796-16-DE
(EUCTR)
09/07/201220/03/2012Study to evaluate the efficacy and safety of human immuneglobulin 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 THROMBOCYTOPENIA Primary 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%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Germany;Czech Republic;Poland;Bulgaria
129EUCTR2011-000831-10-GB
(EUCTR)
02/07/201228/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
130EUCTR2011-000831-10-AT
(EUCTR)
05/06/201216/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2012-000796-16-CZ
(EUCTR)
29/05/201204/04/2012Study to evaluate the efficacy and safety of human immuneglobulin 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 THROMBOCYTOPENIA Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Czech Republic;Poland;Bulgaria;Germany
132EUCTR2011-000831-10-ES
(EUCTR)
25/05/201229/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
133EUCTR2011-000831-10-NL
(EUCTR)
24/05/201224/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA 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 ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden;Korea, Republic of
134EUCTR2011-002184-17-DE
(EUCTR)
04/05/201213/12/2011Study 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 ITP To 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
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Glaxosmithkline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
75United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
135EUCTR2011-002184-17-PL
(EUCTR)
17/04/201208/03/2012Study 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). - PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP To 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
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Glaxosmithkline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
75United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT01433978
(ClinicalTrials.gov)
March 26, 201213/9/2011A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (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: Avatrombopag;Drug: Standard of careEisai Inc.NULLTerminated18 Years99 YearsAll24Phase 3United States
137EUCTR2011-002184-17-IT
(EUCTR)
07/03/201208/03/2012Study 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).PETIT2: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT2 To 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
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
75United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Israel;Italy;United Kingdom;Argentina;Poland;Germany
138EUCTR2011-002184-17-GB
(EUCTR)
02/03/201217/01/2012Study 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 ITP To 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]
Glaxosmithkline Research and Development LtdNULLNot Recruiting Female: yes
Male: yes
75Phase 3United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
139NCT01520909
(ClinicalTrials.gov)
March 201221/12/2011Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (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). PETIT2: Eltrombopag in PEdiatric Patients With Thrombocytopenia From ITPIdiopathic Thrombocytopenic PurpuraDrug: Eltrombopag;Drug: PlaceboGlaxoSmithKlineNULLCompleted1 Year17 YearsAll92Phase 3United States;Argentina;Czech Republic;Germany;Hong Kong;Israel;Italy;Poland;Russian Federation;Spain;Taiwan;Thailand;United Kingdom;Chile
140EUCTR2011-002184-17-ES
(EUCTR)
23/02/201221/12/2011Study 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 ITP Pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP).
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
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Glaxosmithkline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Germany;Chile;Italy;Hong Kong;Israel;Czech Republic;Russian Federation;United Kingdom;Argentina;Taiwan;Spain;Thailand;United States;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2011-002184-17-CZ
(EUCTR)
08/02/201208/12/2011Study 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 ITP To 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
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Product Name: ELTROMBOPAG
Product Code: SB-497115
INN or Proposed INN: ELTROMBOPAG
Other descriptive name: REVOLADE, PROMACTA
Glaxosmithkline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
75Phase 3United States;Hong Kong;Taiwan;Spain;Thailand;Chile;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany
142EUCTR2011-000830-12-CZ
(EUCTR)
19/01/201203/11/2011A 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 applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: PT;Classification code 10043554;Term: Thrombocytopenia;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
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Czech Republic;Slovakia;Greece;Poland;Belgium;Ukraine;Singapore;Australia;South Africa;Bulgaria;Netherlands;New Zealand
143EUCTR2011-000830-12-PL
(EUCTR)
16/01/201217/11/2011A 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 applicable Chronic 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;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;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
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Slovakia;Greece;Ukraine;Austria;Czech Republic;Poland;Belgium;Singapore;Romania;South Africa;Bulgaria;Netherlands;New Zealand
144EUCTR2009-014589-24-BG
(EUCTR)
04/01/201213/09/2011NAProspective, 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-02 Primary Immune Thrombocytopenia (ITP)
MedDRA version: 16.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NewGAM
Product Code: NewGAM
INN or Proposed INN: Immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
95Phase 3France;Czech Republic;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;India
145NCT01444417
(ClinicalTrials.gov)
January 201229/9/2011Safety 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: PlaceboAmgenNULLCompleted1 Year17 YearsAll62Phase 3United States;Australia;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT01549054
(ClinicalTrials.gov)
January 201231/1/2012A 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.NULLCompleted18 Years55 YearsBoth28Phase 1United Kingdom
147EUCTR2011-000830-12-BE
(EUCTR)
30/12/201120/09/2011A 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 applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;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
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hungary;Czech Republic;Belgium;Poland;Portugal;Hong Kong;Slovakia;Greece;Ukraine;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
148EUCTR2011-000830-12-BG
(EUCTR)
21/12/201112/12/2011A 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 applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;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
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Portugal;Hong Kong;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;South Africa;Netherlands;New Zealand;China
149EUCTR2011-000263-27-BG
(EUCTR)
14/11/201125/08/2011An 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 ITP Chronic immune thrombocytopenic purpura (ITP)
MedDRA version: 16.0;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®
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
150Serbia;Poland;Turkey;Bulgaria
150EUCTR2011-001354-29-HU
(EUCTR)
09/11/201112/10/2011An 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
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
40France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2011-001354-29-IT
(EUCTR)
09/11/201107/03/2012An efficacy and safety study of 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 criteriaadopting the new consensus terminology proposed by an internationalworking group (Rodeghiero et al, 2009)
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]
Product Name: human normal immunoglobulin for intravenous use
Product Code: I10E
INN or Proposed INN: NA
Other descriptive name: NA
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
40Hungary;Spain;Ukraine;Russian Federation;Germany;Italy
152JPRN-JMA-IIA00070
31/10/201112/08/2011R-ITP: Clinical Evaluation of Rituximab in Primary Immune ThrombocytopeniaR-ITP: Clinical Evaluation of Rituximab in Primary Immune Thrombocytopenia Idiopathic Thrombocytopenic PurpuraIntervention type:DRUG. Intervention1:rituximab, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP.Keio University School of Medicine , Yoshitaka miyakawaNULLCompleted>=20 YEARSNo LimitBOTH24Phase 3Japan
153EUCTR2011-001354-29-DE
(EUCTR)
12/10/201106/10/2011An 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
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
Other descriptive name: human Immunoglobulin
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
40France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy
154NCT01349790
(ClinicalTrials.gov)
October 20115/5/2011Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune ThrombocytopeniaProspective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune ThrombocytopeniaPrimary ThrombocytopeniaDrug: NewGamOctapharmaNULLCompleted18 Years65 YearsAll40Phase 3Germany
155EUCTR2011-000830-12-SK
(EUCTR)
28/09/201126/08/2011A 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 applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Portugal;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2009-014589-24-DE
(EUCTR)
22/09/201112/04/2011NAProspective, 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-02 Primary 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
INN or Proposed INN: Immunglobulin
Other descriptive name: IMMUNOGLOBULIN G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
95Phase 3France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
157EUCTR2009-014589-24-CZ
(EUCTR)
02/09/201126/04/2011NAProspective, 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-02 Primary 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
INN or Proposed INN: immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
95Phase 3France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India
158NCT01437384
(ClinicalTrials.gov)
September 201119/9/2011Pharmacokinetic 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.NULLCompleted18 Years55 YearsBoth36Phase 1United States
159EUCTR2011-000263-27-PL
(EUCTR)
22/07/201108/06/2011An 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 ITP Chronic 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®
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring LLCNULLNot RecruitingFemale: yes
Male: yes
150Serbia;Poland;Turkey;Bulgaria
160EUCTR2006-002946-13-NL
(EUCTR)
19/04/201115/12/2010A 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 idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETITA 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 idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
70France;Spain;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT01327872
(ClinicalTrials.gov)
February 201130/3/2011Subject 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.NULLCompleted18 Years55 YearsBoth84Phase 1Netherlands
162NCT01416311
(ClinicalTrials.gov)
December 21, 20109/6/2011Drug Use Investigation for REVOLADE (ITP)Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)Purpura, Thrombocytopaenic, IdiopathicDrug: EltrombopagNovartis PharmaceuticalsNULLCompletedN/AN/AAll5797NULL
163EUCTR2010-019987-35-CZ
(EUCTR)
21/12/201026/11/2010Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving RomiplostimA Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim Adult immune thrombocytopenic purpura (ITP)
MedDRA version: 16.0;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: Nplate
Product Name: romiplostim
Product Code: AMG 531
INN or Proposed INN: romiplostim
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
75Phase 2France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy
164NCT01143038
(ClinicalTrials.gov)
November 30, 201010/6/2010Interventional 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: RomiplostimAmgenNULLCompleted18 YearsN/AAll75Phase 2United States;Australia;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom;Czech Republic
165EUCTR2010-019987-35-GB
(EUCTR)
29/10/201026/08/2010 Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving RomiplostimA Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim Adult immune thrombocytopenic purpura (ITP)
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] - Blood and lymphatic diseases [C15]
Amgen IncNULLNot Recruiting Female: yes
Male: yes
75Phase 2France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2010-019987-35-DE
(EUCTR)
21/10/201025/08/2010Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving RomiplostimA Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim Adult immune thrombocytopenic purpura (ITP)
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] - Blood and lymphatic diseases [C15]
Trade Name: Nplate
Product Name: romiplostim
Product Code: AMG 531
INN or Proposed INN: romiplostim
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
75Phase 2France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy
167EUCTR2008-004347-10-BG
(EUCTR)
14/10/201012/05/2010A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia 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
INN or Proposed INN: Romiplostim
Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Hungary;Germany;Bulgaria;Italy;Austria;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Estonia;Spain;Poland
168EUCTR2010-019987-35-ES
(EUCTR)
22/09/201031/08/2010Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving RomiplostimEstudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim Púrpura Trombocitopénica Inmune(Idiopática) (PTI) en adultos----------------------------------Adult immune thrombocytopenic purpura (ITP)
MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Trade Name: NPLATE 500 microgramos polvo para solución inyectable
INN or Proposed INN: ROMIPLOSTIM
Other descriptive name: ROMIPLOSTIM
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czech Republic;United Kingdom;Germany;Spain;Italy
169EUCTR2009-010421-39-FR
(EUCTR)
25/05/201009/03/2010A 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: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: eltrombopag (Revolade)
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: eltrombopag (Revolade)
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: eltrombopag (Revolade)
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: eltrombopag (Revolade)
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 4France;Hungary;Czech Republic;Germany;Italy
170EUCTR2009-010421-39-CZ
(EUCTR)
06/05/201003/03/2010A 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: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
150France;Hungary;Czech Republic;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2009-010421-39-HU
(EUCTR)
05/05/201010/03/2010A 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: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
150France;Czech Republic;Hungary;Germany;Italy
172EUCTR2009-010421-39-DE
(EUCTR)
10/03/201004/02/2010A 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
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
Product Name: Revolade
Product Code: SB497115
INN or Proposed INN: ELTROMBOPAG
GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
200France;Hungary;Czech Republic;Germany;Italy
173EUCTR2009-014842-28-PL
(EUCTR)
21/01/201002/10/2009A study to assess the safety and effectiveness of the study drug(SM101) versus placebo( dummy treatment)in adult patients with chronic Primary Immune Thrombocytopenia(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 Primary Immune Thrombocytopenia (ITP). Primary Immune Thrombocytopenia
MedDRA version: 15.1;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: SM101 20mg/mL
Product Code: SM101
INN or Proposed INN: SM101
Product Name: SM101 5mg/mL
Product Code: SM101
INN or Proposed INN: SM101
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
69Phase Ib/2aBelgium;Poland;Ukraine;Russian Federation;Germany
174EUCTR2009-014842-28-DE
(EUCTR)
14/01/201021/09/2009A study to assess the safety and effectiveness of the study drug (SM101) versus a placebo (dummy treatment) in adult patients with chronic Primary Immune Thrombocytopenia (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 Primary Immune Thrombocytopenia (ITP). Primary Immune Thrombocytopenia
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: SM101 20mg/mL
Product Code: SM101
INN or Proposed INN: SM101
Product Name: SM101 5mg/mL
Product Code: SM101
INN or Proposed INN: SM101
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
69Phase Ib/2aBelgium;Poland;Ukraine;Russian Federation;Germany
175EUCTR2009-014842-28-BE
(EUCTR)
06/01/201014/09/2009A 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
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
51Phase 1;Phase 2Poland;Belgium;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT03258866
(ClinicalTrials.gov)
January 1, 201018/8/2017The 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 UniversityNULLCompleted10 Years70 YearsAll62Phase 4China
177NCT01071954
(ClinicalTrials.gov)
December 30, 200917/12/2009A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients 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: RomiplostimAmgenNULLCompleted1 YearN/AAll66Phase 3United States;Australia;Canada;Spain
178EUCTR2008-004347-10-SI
(EUCTR)
12/11/200906/10/2009A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia 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
INN or Proposed INN: Romiplostim
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
179EUCTR2008-004347-10-IT
(EUCTR)
07/10/200916/09/2009A 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: 14.1;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: NPLATE
INN or Proposed INN: ROMIPLOSTIM
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
180NCT00908037
(ClinicalTrials.gov)
September 30, 200921/5/2009Efficacy 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: PlaceboGlaxoSmithKlineNULLCompleted1 Year17 YearsAll82Phase 2United States;Canada;France;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2006-002946-13-GB
(EUCTR)
18/09/200906/07/2009 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 idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT 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 idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
70Phase 2France;Spain;Netherlands;United Kingdom
182EUCTR2006-002946-13-FR
(EUCTR)
18/09/200905/08/2009A 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 idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETITA 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 idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT Chronic Idiopathic Thrombocytopenic Purpura
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70United Kingdom;Netherlands;France;Spain
183EUCTR2008-004347-10-SE
(EUCTR)
09/09/200924/06/2009A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia 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
INN or Proposed INN: Romiplostim
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
184NCT00907478
(ClinicalTrials.gov)
August 11, 200921/5/2009Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune 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;Idiopathic Thrombocytopenic PurpuraBiological: romiplostimAmgenNULLCompleted18 YearsN/AAll169Phase 4Australia;Austria;Belgium;Canada;Czech Republic;Estonia;Germany;Hungary;Italy;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovenia;Spain;Sweden;United States
185EUCTR2006-002946-13-ES
(EUCTR)
30/07/200906/07/2009A 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 idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETITA 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 idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETIT Chronic Idiopathic Thrombocytopenic PurpuraPúrpura Trombocitopénica Idiopática Crónica
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
GlaxoSmithKline S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15United Kingdom;Netherlands;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2008-004347-10-ES
(EUCTR)
16/07/200905/06/2009A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)?A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)? Thrombocytopenia associated with ITP.---------------------------trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim
Trade Name: Nplate
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Hungary;Germany;Bulgaria;Italy;Austria;Sweden;Lithuania;Czech Republic;Belgium;Slovenia;Estonia;Spain;Poland
187EUCTR2008-004347-10-BE
(EUCTR)
10/07/200929/05/2009A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia 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
INN or Proposed INN: Romiplostim
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Sweden
188EUCTR2008-001597-33-NL
(EUCTR)
18/06/200929/05/2008Development 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 ITP Acute 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
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Netherlands
189EUCTR2008-004347-10-AT
(EUCTR)
17/06/200906/05/2009A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia 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
INN or Proposed INN: Romiplostim
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 4Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden
190EUCTR2008-005871-92-SE
(EUCTR)
05/02/200910/12/2008En 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 ITP Chronic idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 9.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Trade Name: Tysabri
Product Name: Tysabri
Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2007-000638-37-IE
(EUCTR)
06/01/200910/04/2008An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)An Open Label Study of AMG 531 in Severely Refractory 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: AMG 531
Product Code: AMG 531
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
192EUCTR2005-005918-20-FR
(EUCTR)
23/12/200823/10/2008Rituximab 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 study Immune thrombocytopenic purpura (ITP)
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Trade Name: MabThera
Product Name: MabThera
Other descriptive name: RITUXIMAB
RikshospitaletNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United Kingdom;France;Sweden
193EUCTR2007-000638-37-SK
(EUCTR)
17/12/200827/10/2008An 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
INN or Proposed INN: Romiplostim
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2Czech Republic;Slovakia;Spain;Belgium;Ireland;Austria;Netherlands;Italy;United Kingdom
194EUCTR2007-000638-37-ES
(EUCTR)
17/12/200817/10/2008An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP).-------------------------------------------------------?Estudio Abierto de Romiplostim en Sujetos Adultos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)?An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP).-------------------------------------------------------?Estudio Abierto de Romiplostim en Sujetos Adultos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)? Immune (Idiopathic) Thrombocytopenic Purpura.-------------------------------------------Púrpura Trombocitopénica Inmune (Idiopática)
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Romiplostim
Product Code: AMG 531
INN or Proposed INN: Romiplostim
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Ireland;Spain;Italy;Austria
195NCT00860600
(ClinicalTrials.gov)
September 200810/3/2009Safety and Efficacy Study of PG2 to Treat Idiopathic Thrombocytopenic Purpura (ITP) PatientsThe Clinical Trial of PG2 in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)Idiopathic Thrombocytopenic Purpura (ITP)Drug: PG2PhytoHealth CorporationNULLCompleted18 YearsN/AAll14Phase 2Taiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2004-000172-13-GB
(EUCTR)
20/08/200811/02/2005An 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 available Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Amgen Inc.NULLNot Recruiting Female: yes
Male: yes
350Phase 3Czech Republic;Belgium;Austria;Germany;Italy;United Kingdom
197EUCTR2007-000638-37-GB
(EUCTR)
18/08/200811/04/2008An 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
INN or Proposed INN: Romiplostim
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
500Czech Republic;United Kingdom;Netherlands;Belgium;Spain;Ireland;Italy;Austria
198EUCTR2006-000471-14-IE
(EUCTR)
02/08/200805/07/2006EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
199NCT00749112
(ClinicalTrials.gov)
August 20088/9/2008Alemtuzumab 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. GonzalezNULLCompleted16 YearsN/ABoth19Phase 2;Phase 3Mexico
200EUCTR2004-000172-13-IT
(EUCTR)
22/07/200810/07/2008AN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURAAN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURA Thrombocytopenia in subjects with ITP
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] - Blood and lymphatic diseases [C15]
Product Name: AMG531
Product Code: AMG531
INN or Proposed INN: AMG531
AMGEN S.P.A.NULLNot RecruitingFemale: yes
Male: yes
350Czech Republic;Belgium;Austria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2008-000417-30-IT
(EUCTR)
19/06/200811/04/2008Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207 ITP Primary Immune Thrombocytopenic Purpura in newly diagnosed untreated adult patients
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Dexamethasone
INN or Proposed INN: Dexamethasone
Product Name: Prednisone
INN or Proposed INN: Prednisone
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
202EUCTR2004-000172-13-CZ
(EUCTR)
11/06/200811/04/2008An 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 available Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Code: AMG 531Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Czech Republic;Belgium;Italy;Austria
203EUCTR2007-000638-37-IT
(EUCTR)
09/06/200804/08/2008An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209 Thrombocytopenia in subjects with ITP
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: AMG531
Product Code: AMG531
AMGEN S.P.A.NULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
204EUCTR2004-000172-13-AT
(EUCTR)
13/05/200810/03/2008An 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 available Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Code: AMG 531Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
350Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria
205EUCTR2004-000172-13-DE
(EUCTR)
07/05/200807/02/2008An 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 available Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Code: AMG 531Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
350Czech Republic;United Kingdom;Germany;Belgium;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT00828750
(ClinicalTrials.gov)
May 200822/1/2009Clinical 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 tabletsGlaxoSmithKlineNULLCompleted20 YearsN/AAll19Phase 3Japan
207EUCTR2007-000638-37-AT
(EUCTR)
30/04/200804/03/2008An 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
INN or Proposed INN: Romiplostim
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
208EUCTR2007-000638-37-CZ
(EUCTR)
09/04/200811/02/2008An 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
INN or Proposed INN: Romiplostim
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
209EUCTR2004-000172-13-BE
(EUCTR)
08/04/200827/02/2008An 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 available Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Code: AMG 531Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
350Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria
210EUCTR2007-000638-37-BE
(EUCTR)
13/03/200827/02/2008An 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
INN or Proposed INN: Romiplostim
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2007-000638-37-NL
(EUCTR)
28/02/200829/11/2007An 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
INN or Proposed INN: Romiplostim
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria
212NCT00571467
(ClinicalTrials.gov)
December 200710/12/2007Phase 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.NULLTerminated18 YearsN/AAll9Phase 1Australia;New Zealand
213EUCTR2006-000471-14-FI
(EUCTR)
30/11/200708/10/2007EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
214EUCTR2006-000471-14-IT
(EUCTR)
16/11/200713/09/2007EXTEND (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. - TRA105325EXTEND (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. - TRA105325 Idiopathic thrombocytopenic purpura
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115-GR
INN or Proposed INN: Eltrombopag
Product Name: Eltrombopag
Product Code: SB-497115-GR
INN or Proposed INN: Eltrombopag
GLAXOSMITHKLINE R&D LTDNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
215EUCTR2006-000471-14-AT
(EUCTR)
11/11/200723/10/2007EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2006-000471-14-DE
(EUCTR)
26/10/200730/05/2006EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
217NCT00603642
(ClinicalTrials.gov)
October 1, 200717/1/2008P3 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 531AmgenNULLCompleted20 YearsN/AAll34Phase 3Japan
218EUCTR2006-000470-78-CZ
(EUCTR)
01/10/200730/11/2006A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
219EUCTR2006-000471-14-DK
(EUCTR)
01/10/200714/08/2007EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
220EUCTR2007-003569-42-ES
(EUCTR)
29/09/200703/08/2007Estudio 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) Crónica Púrpura 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
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT00540423
(ClinicalTrials.gov)
September 20075/10/2007Clinical 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 mgGlaxoSmithKlineNULLCompleted20 YearsN/AAll23Phase 3Japan
222NCT00504075
(ClinicalTrials.gov)
September 200718/7/2007A 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 LaboratoryNULLCompleted18 Years70 YearsAll35Phase 3United States;Argentina;India
223EUCTR2006-000471-14-CZ
(EUCTR)
16/08/200724/07/2007EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
224NCT00515203
(ClinicalTrials.gov)
July 20079/8/2007Safety 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 531AmgenNULLCompleted1 Year17 YearsAll22Phase 1;Phase 2Australia;Canada;Spain;United States
225EUCTR2006-003700-18-PT
(EUCTR)
04/06/200706/02/2007A 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 Purpura Immune (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
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT00362349
(ClinicalTrials.gov)
June 20079/8/2006Ig 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 LimitedNULLCompleted18 YearsN/ABoth19Phase 3Australia
227EUCTR2006-003700-18-CZ
(EUCTR)
25/05/200707/02/2007A 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 Purpura Immune (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
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy;Austria
228EUCTR2005-003552-35-FR
(EUCTR)
10/05/200729/12/2006Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/AClinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A the medical condition which have to be investigated is the evolution of platelets counts in adults with a idiopathic thrombocytopenic purpura, with less than 20 10^9 platelets/L and treated by Octagam10% (immunoglobulines).Product Name: Octagam® 10%
INN or Proposed INN: Human Immunoglobulin
Octapharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
116Czech Republic;Germany;France
229EUCTR2006-003700-18-DE
(EUCTR)
08/05/200725/04/2007A 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 Purpura Immune (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
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Italy;Austria
230NCT00475423
(ClinicalTrials.gov)
May 200717/5/2007A 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 RocheNULLCompleted18 YearsN/AAll122Phase 2Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT00625443
(ClinicalTrials.gov)
May 200719/2/2008Phase 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.NULLCompleted18 YearsN/AAll53Phase 2United States
232EUCTR2006-002943-10-ES
(EUCTR)
19/04/200721/02/2007REPEAT. 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) - REPEAT Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Germany;United Kingdom;Spain
233EUCTR2006-002943-10-GB
(EUCTR)
13/04/200726/02/2007 REPEAT. 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) - REPEAT REPEAT. 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) - REPEAT Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
50Phase 2Spain;Germany;United Kingdom
234EUCTR2006-000470-78-GR
(EUCTR)
27/03/200703/01/2007A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
235EUCTR2006-003700-18-BE
(EUCTR)
26/03/200721/03/2007A 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 Purpura Immune (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
INN or Proposed INN: AMG 531
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2006-002943-10-DE
(EUCTR)
16/03/200728/03/2007REPEAT. 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) - REPEAT Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
50United Kingdom;Germany;Spain
237EUCTR2006-003700-18-GB
(EUCTR)
08/03/200701/01/2007A 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 Purpura Immune (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
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3Portugal;France;Czech Republic;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom
238NCT00424177
(ClinicalTrials.gov)
March 200717/1/2007Repeated 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: eltrombopagGlaxoSmithKlineNULLCompleted18 YearsN/AAll66Phase 2Germany;Russian Federation;Australia;Canada;India;Korea, Republic of;Netherlands;Spain;Tunisia;United Kingdom;United States
239EUCTR2006-000471-14-GR
(EUCTR)
27/02/200704/09/2006EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
240EUCTR2006-000470-78-DE
(EUCTR)
14/02/200705/12/2006A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Czech Republic;Germany;Netherlands;France;Spain;Italy;Greece;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2006-003700-18-AT
(EUCTR)
05/02/200721/12/2006A 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 Purpura Immune (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
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
242NCT00441090
(ClinicalTrials.gov)
February 200727/2/2007Study 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: Avatrombopag tabletsEisai Inc.NULLCompleted18 YearsN/AAll64Phase 2United States
243EUCTR2006-003700-18-FR
(EUCTR)
31/01/200711/01/2007A 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 Purpura Immune (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
INN or Proposed INN: AMG 531
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
244EUCTR2006-003700-18-NL
(EUCTR)
29/01/200712/09/2007A 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 Purpura Immune (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
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
245EUCTR2006-000471-14-SK
(EUCTR)
23/01/200730/11/2006Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial.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 - EXTEND chronic immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 17.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2006-000470-78-IT
(EUCTR)
17/01/200705/02/2007RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A 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 . - RAISE RAndomized placebo-controlled ITP Study with EltrombopagRAISE RAndomized placebo-controlled ITP Study with Eltrombopag A 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 . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag Idiopathic thrombocytopenic purpura ITP
MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB-497115-GR
Product Name: Eltrombopag
Product Code: SB-497115-GR
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
247EUCTR2006-000470-78-SK
(EUCTR)
17/01/200730/11/2006A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
248EUCTR2006-000470-78-FR
(EUCTR)
22/12/200616/11/2006A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
249EUCTR2006-000470-78-FI
(EUCTR)
12/12/200625/10/2006A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
250NCT00415532
(ClinicalTrials.gov)
December 1, 200621/12/2006Romiplostim (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: RomiplostimAmgenNULLCompleted18 YearsN/AAll234Phase 3Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT00392951
(ClinicalTrials.gov)
December 200624/10/2006Sirolimus 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 PhiladelphiaNULLCompleted1 Year30 YearsAll30Phase 1;Phase 2United States
252EUCTR2006-000470-78-DK
(EUCTR)
29/11/200610/11/2006A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3France;Czech Republic;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy
253EUCTR2006-000470-78-GB
(EUCTR)
22/11/200608/05/2008A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
189Phase 3France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;Italy;United Kingdom
254EUCTR2006-000470-78-ES
(EUCTR)
22/11/200613/04/2012A 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).A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
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: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 3Germany;France;Hong Kong;Austria;Brazil;Czech Republic;Tunisia;Canada;New Zealand;Peru;Greece;United States;Poland;Netherlands;Italy;Vietnam;Finland;India;Russian Federation;Slovakia;United Kingdom;Denmark;Taiwan;Estonia;China;Spain
255EUCTR2006-000470-78-AT
(EUCTR)
22/11/200620/11/2006A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT00370331
(ClinicalTrials.gov)
November 200629/8/2006RAISE: 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: PlaceboGlaxoSmithKlineNULLCompleted18 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
257EUCTR2006-000470-78-NL
(EUCTR)
30/10/200601/09/2006A 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). - RAISE Idiopathic thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
189Phase 3Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria
258EUCTR2006-000471-14-GB
(EUCTR)
23/10/200603/06/2007EXTEND (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 - EXTEND Immune Thrombocytopenic Purpura (ITP)
MedDRA version: 12.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
400Phase 3Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
259EUCTR2006-000471-14-NL
(EUCTR)
23/08/200621/07/2006EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Germany;Sweden
260EUCTR2006-000471-14-SE
(EUCTR)
14/08/200629/05/2006Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial.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 - EXTEND chronic immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 18.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2006-000471-14-FR
(EUCTR)
16/06/200624/11/2006EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)
MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden
262EUCTR2006-000471-14-SI
(EUCTR)
13/06/200623/05/2006EXTEND (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 - EXTEND Immune thrombocytopenic purpura (ITP)Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
INN or Proposed INN: Eltrombopag
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
200Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Slovenia;Denmark;Spain;Greece
263NCT00426270
(ClinicalTrials.gov)
June 200622/1/2007Clinical 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%OctapharmaNULLCompleted18 YearsN/AAll116Phase 3Austria
264NCT00351468
(ClinicalTrials.gov)
June 200610/7/2006EXTEND (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 PharmaceuticalsNULLCompleted18 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
265EUCTR2005-003552-35-DE
(EUCTR)
28/03/200613/01/2006Clinical 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/A Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.
MedDRA version: 7.0;Level: LLT;Classification code 10021245
Product Name: Octagam® 10%
INN or Proposed INN: Human Immunoglobulin G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
116Czech Republic;Germany;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266EUCTR2005-003552-35-CZ
(EUCTR)
13/03/200623/01/2006Clinical study to evaluate the efficacy and safety of Octagam(R) 10% in Idiopathic Thrombocytopenic Purpura in adults - NAClinical study to evaluate the efficacy and safety of Octagam(R) 10% in Idiopathic Thrombocytopenic Purpura in adults - NA Idiopathic Thrombocytopenic Purpura in adults actively bleeding or at high risk of bleeding
MedDRA version: 7.0;Level: LLT;Classification code 10021245
Product Name: Octagam 10%Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
116Germany;Czech Republic;France
267EUCTR2005-003552-35-AT
(EUCTR)
20/02/200616/01/2006Clinical 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/A Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding.
MedDRA version: 7.0;Level: LLT;Classification code 10021245
Product Name: Octagam® 10%
INN or Proposed INN: Human Immunoglobulin G
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
116France;Czech Republic;Austria;Germany
268NCT00451594
(ClinicalTrials.gov)
September 200522/3/2007High 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 HematologyNULLCompleted16 YearsN/ABoth157Phase 3Korea, Republic of
269NCT00244257
(ClinicalTrials.gov)
August 200525/10/2005Safety 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 CompanyNULLTerminated18 YearsN/ABoth10Phase 1United States
270NCT00770562
(ClinicalTrials.gov)
July 20059/10/2008A 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 RocheNULLCompleted18 YearsN/AAll103Phase 3Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2005-000859-15-IT
(EUCTR)
14/04/200520/06/2005Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults.Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults. Front-line treatment of adult ITP
MedDRA version: 6.1;Level: PT;Classification code 10021245
Trade Name: Mabthera
INN or Proposed INN: Rituximab
Trade Name: Mabthera
INN or Proposed INN: Rituximab
ROCHENULLNot RecruitingFemale: yes
Male: yes
Italy
272NCT00102336
(ClinicalTrials.gov)
April 7, 200527/1/2005AMG 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: PlaceboAmgenNULLCompleted18 YearsN/AAll62Phase 3United States
273NCT00102323
(ClinicalTrials.gov)
March 29, 200527/1/2005AMG 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 531AmgenNULLCompleted18 YearsN/AAll63Phase 3France;Netherlands;Spain;United States
274NCT00508820
(ClinicalTrials.gov)
February 1, 200526/7/2007An 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: RomiplostimAmgenNULLCompleted18 YearsN/AAll407Phase 3Australia;Austria;Belgium;Canada;Czech Republic;Ireland;Italy;Netherlands;Poland;Slovakia;Spain;Switzerland;United Kingdom;United States
275NCT00116688
(ClinicalTrials.gov)
August 200430/6/2005Open 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: RomiplostimAmgenNULLCompleted1 YearN/AAll313Phase 3Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT00909077
(ClinicalTrials.gov)
August 200426/5/2009The 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 HerlevNULLCompleted18 YearsN/AAll155Phase 3Denmark
277NCT00162006
(ClinicalTrials.gov)
January 1, 20038/9/2005Efficacy 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 ShireNULLCompleted18 Years65 YearsAll28Phase 2Czechia;Germany;Hungary;Poland;Czech Republic
278NCT00111475
(ClinicalTrials.gov)
July 1, 200220/5/2005Evaluating the Safety and Efficacy of Romiplostim (AMG 531) 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: Romiplostim;Drug: PlaceboAmgenNULLCompleted18 Years65 YearsAll45Phase 2NULL
279NCT00151840
(ClinicalTrials.gov)
October 20018/9/2005Efficacy 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-LSanquinNULLCompleted18 YearsN/ABoth20Phase 3Poland
280NCT00107913
(ClinicalTrials.gov)
September 200111/4/2005Study 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 SpecialistsNULLRecruitingN/AN/ABoth10Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281EUCTR2011-005586-21-Outside-EU/EEA
(EUCTR)
07/12/2011A research study to determine if an experimental IVIG product, Gammaplex®, is safe, tolerable, and effective when given to patients who have Idiopathic Thrombocytopenic PurpuraA Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura - n/a Idiopathic thrombocytopenic purpura.
MedDRA version: 14.0;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gammaplex
Product Name: Gammaplex
Product Code: n/a
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Bio Products Laboratory LimitedNULLNAFemale: yes
Male: yes
35Phase 3Argentina;India;United States
282EUCTR2020-003232-24-PL
(EUCTR)
28/10/2020Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune ThrombocytopeniaA Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment
MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Doptelet 20 mg film-coated tablets
Product Name: avatrombopag
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AVATROMBOPAG MALEATE
Dova Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
72Phase 3United States;France;Hungary;Czech Republic;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom
283EUCTR2020-003232-24-DE
(EUCTR)
27/10/2020Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune ThrombocytopeniaA Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment
MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Doptelet 20 mg film-coated tablets
Product Name: avatrombopag
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AVATROMBOPAG MALEATE
Dova Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
72Phase 3United States;France;Hungary;Czech Republic;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom
284EUCTR2006-002946-13-Outside-EU/EEA
(EUCTR)
24/02/2012A study of a new medication, eltrombopag, for the treatment of 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 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 idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT Chronic Idiopathic Thrombocytopenic Purpura
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
INN or Proposed INN: Eltrombopag
Other descriptive name: REVOLADE, PROMACTA
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Other descriptive name: REVOLADE, PROMACTA
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Other descriptive name: REVOLADE, PROMACTA
Product Name: Eltrombopag
Product Code: SB-497115
INN or Proposed INN: Eltrombopag
Other descriptive name: REVOLADE, PROMACTA
GlaxoSmithKline Research & Development LimitedNULLNAFemale: yes
Male: yes
70Canada;United States