63. 特発性血小板減少性紫斑病 Idiopathic thrombocytopenic purpura Clinical trials / Disease details


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139

  
18 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2020-004032-21-DK
(EUCTR)
11/01/202216/04/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Denmark;Peru;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
2NCT04812925
(ClinicalTrials.gov)
November 17, 202115/3/2021A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaBiological: efgartigimod PH20 SCargenxNULLRecruiting18 YearsN/AAll156Phase 3United States;Argentina;Australia;Bulgaria;Chile;China;Georgia;Greece;Ireland;Italy;Japan;Jordan;Korea, Republic of;Mexico;New Zealand;Poland;Portugal;Romania;Russian Federation;South Africa;Thailand;Tunisia;Turkey;United Kingdom
3EUCTR2020-004033-20-RO
(EUCTR)
06/10/202120/04/2022Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Bulgaria;Georgia;Norway;Germany;New Zealand;Japan
4EUCTR2020-004033-20-NO
(EUCTR)
08/09/202120/04/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
5EUCTR2020-004033-20-GR
(EUCTR)
07/09/202119/07/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
6EUCTR2020-004033-20-BG
(EUCTR)
03/09/202126/05/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
7EUCTR2020-004033-20-PT
(EUCTR)
03/09/202120/05/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
8EUCTR2020-004033-20-ES
(EUCTR)
13/08/202109/06/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
9EUCTR2020-004033-20-IT
(EUCTR)
23/07/202117/08/2021Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
Product Code: [ARGX-113]
INN or Proposed INN: efgartigimod alfa
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
10EUCTR2020-004032-21-PT
(EUCTR)
19/07/202111/03/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
219Phase 3Thailand;Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Australia;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
11EUCTR2020-004032-21-NO
(EUCTR)
25/06/202118/03/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Serbia;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Jordan;Denmark;Australia;Peru;South Africa;Tunisia;Latvia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
12EUCTR2020-004032-21-RO
(EUCTR)
23/06/202125/05/2022A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Serbia;Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Australia;South Africa;Tunisia;Latvia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
13EUCTR2020-004032-21-DE
(EUCTR)
15/06/202112/03/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
14EUCTR2020-004032-21-IT
(EUCTR)
04/06/202108/06/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH20 Subcutaneous in adult patients with primary immune thrombocytopeniaA Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 22.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
Product Code: [ARGX-113]
INN or Proposed INN: efgartigimod alfa
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
15EUCTR2020-004032-21-BG
(EUCTR)
17/05/202115/03/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan
16EUCTR2020-004032-21-IE
(EUCTR)
07/05/202117/02/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Bulgaria;Georgia;Norway;Germany;New Zealand;Japan
17NCT04687072
(ClinicalTrials.gov)
December 11, 202018/12/2020A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaBiological: Efgartigimod PH20 SC;Other: Placebo PH20 SCargenxNULLRecruiting18 YearsN/AAll219Phase 3United States;Argentina;Australia;Bulgaria;Chile;China;Denmark;France;Georgia;Germany;Greece;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Mexico;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;United Kingdom
18EUCTR2020-004032-21-GR
(EUCTR)
19/04/2021A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia.A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC Primary immune thrombocytopenia (ITP)
MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: efgartigimod PH20 SC
INN or Proposed INN: efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Bulgaria;Georgia;Norway;Germany;New Zealand;Japan