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Amg531    (DrugBank: -)

2 diseases
告示番号疾患名（ページ内リンク）臨床試験数
60再生不良性貧血7
63特発性血小板減少性紫斑病2

60. 再生不良性貧血　［臨床試験数：218，薬物数：362（DrugBank：81），標的遺伝子数：39，標的パスウェイ数：155］
Searched query = "Aplastic anemia"
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.
7 / 218 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1JPRN-JapicCTI-194962
03/12/201918/09/2019A Phase 2/3 Study of AMG531 in Patients with Aplastic AnemiaA Phase 2/3 Study of AMG531 Combined with Ciclosporin A in Patients with Aplastic Anemia Previously Untreated with Immunosuppressive Therapy Aplastic AnemiaIntervention name : AMG531
INN of the intervention : romiplostim
Dosage And administration of the intervention : SC-administered
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -		Kyowa Kirin Co., LtdNULLrecruiting20BOTH24Phase 2;Phase 3Japan, Asia except Japan
2NCT04095936
(ClinicalTrials.gov)		December 3, 201918/9/2019Study of AMG531 (Romiplostim) in Patients With Aplastic AnemiaA Phase 2/3 Study of AMG531 Combined With Ciclosporin A in Patients With Aplastic Anemia Previously Untreated With Immunosuppressive TherapyAplastic AnemiaDrug: RomiplostimKyowa Kirin Co., Ltd.NULLRecruiting20 YearsN/AAll24Phase 2;Phase 3Japan
3NCT03957694
(ClinicalTrials.gov)		April 25, 20199/5/2019Study of AMG531(Romiplostim) in Patients With Aplastic AnemiaA Phase 2/3 Study of AMG531 in Patients With Aplastic Anemia PreviouslyUntreated With Immunosuppressive TherapyAplastic AnemiaDrug: RomiplostimKyowa Kirin Co., Ltd.NULLActive, not recruiting20 YearsN/AAll14Phase 2;Phase 3Japan
4JPRN-JapicCTI-194746
01/2/201909/05/2019A Phase 2/3 Study of AMG531 in Patients with Aplastic AnemiaA Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia Previously Untreated with Immunosuppressive Therapy Aplastic AnemiaIntervention name : AMG531
INN of the intervention : romiplostim
Dosage And administration of the intervention : SC-administered
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -		Kyowa Kirin Co., LtdNULLcomplete20BOTH14Phase 2;Phase 3Japan, Asia except Japan
5NCT02773290
(ClinicalTrials.gov)		May 20169/5/2016Study of Romiplostim(AMG531) in Subjects With Aplastic AnemiaPhase 2/3 Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Refractory to or Ineligible for Immunosuppressive TherapyAplastic AnemiaBiological: RomiplostimKyowa Kirin Co., Ltd.NULLActive, not recruiting20 YearsN/AAll46Phase 2;Phase 3Japan;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
6JPRN-JapicCTI-163243
01/2/201602/05/2016Phase 2/3 Study of AMG531 in Subjects with Aplastic AnemiaPhase 2/3 Study of AMG531 in Subjects with Aplastic Anemia Refractory to or Ineligible for Immunosuppressive Therapy Aplastic AnemiaIntervention name : AMG531
INN of the intervention : Romiplostim
Dosage And administration of the intervention : Subcutaneous administration		Kyowa Hakko Kirin Co., Ltd.NULLcomplete20BOTH46Phase 2;Phase 3NULL
7NCT02094417
(ClinicalTrials.gov)		April 14, 201418/3/2014A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic AnemiaA Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Finding Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia Subjects With Thrombocytopenia Refractory to Immunosuppressive TherapyAplastic AnemiaDrug: AMG531Kyowa Kirin Korea Co., Ltd.NULLCompleted19 YearsN/AAll35Phase 2Korea, Republic of

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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.
2 / 311 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2004-000172-13-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
2EUCTR2007-000638-37-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

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