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"
22 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-GB16/12/202029/10/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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-DE15/12/202026/10/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
3EUCTR2019-002101-21-NL25/05/202007/01/2020A 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: 20.1Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
4EUCTR2019-002101-21-BG08/05/202024/04/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
5EUCTR2019-002101-21-CZ06/05/202010/03/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-002100-41-AT30/04/202025/11/2019A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
7EUCTR2019-002101-21-BE28/04/202003/03/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
8EUCTR2019-002101-21-FR22/04/202020/02/2020A 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: 20.1Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
9EUCTR2019-002100-41-DE14/04/202025/11/2019A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
10EUCTR2019-002101-21-ES09/04/202023/01/2020A 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: 20.1Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
11EUCTR2019-002101-21-HU07/04/202031/01/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
12EUCTR2019-002100-41-GB10/01/202005/08/2020A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
13EUCTR2019-002100-41-BE10/01/202021/11/2019A 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: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem 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
14EUCTR2019-000361-21-GB30/04/201906/02/2020A 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: 20.1Level: LLTClassification code 10074678Term: Primary immune thrombocytopenic purpuraSystem 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
15EUCTR2016-003038-26-DE27/04/201708/12/2016A 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
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Czech Republic;Poland;Belgium;Spain;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
16NCT03102593March 13, 201714/3/2017A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITPA Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaDrug: ARGX-113;Other: PlaceboargenxQuintiles, Inc.Completed18 Years85 YearsAll38Phase 2Austria;Belgium;Czechia;France;Germany;Hungary;Poland;Spain;Ukraine;United Kingdom;Czech Republic
17EUCTR2016-003038-26-CZ10/02/201702/12/2016A 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
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
18EUCTR2016-003038-26-GB08/02/201716/11/2016A 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: 20.1Level: LLTClassification code 10074678Term: Primary immune thrombocytopenic purpuraSystem 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
19EUCTR2016-003038-26-ES07/02/201727/12/2016A 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
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom
20EUCTR2016-003038-26-AT06/02/201714/12/2016A 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
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Czech Republic;Poland;Belgium;Spain;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
21EUCTR2016-003038-26-BE27/01/201708/12/2016A 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: 20.1Level: LLTClassification code 10074678Term: Primary immune thrombocytopenic purpuraSystem 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
22EUCTR2016-003038-26-HU19/01/201730/11/2016A 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
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Czech Republic;Hungary;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom