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

  
47 trials found
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PhaseCountries
1JPRN-jRCT2071210087
04/02/202229/10/2021A 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 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 - ADVANCESC+ Primary Immune ThrombocytopeniaPatients will receive ARGX-113 PH20 SC (1000 mg of Efgartigimod Alfa) weekly or biweekly ( continue as in the ARGX-113-2004 trial), and a change in dosing frequency is permitted as from visit 1 (baseline)Gandini DomenicaNULLRecruiting>= 20age oldNot applicableBoth9Phase 3Argentina;Australia;Bulgaria;Chile;China;Colombia;Denmark;France;Georgia;Germany;Greece;Ireland;Israel;Italy;Jordan;Republic of Korea;Latvia;Mexico;New Zealand;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Japan
2EUCTR2020-004032-21-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
3NCT04812925
(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
4EUCTR2020-004033-20-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
5EUCTR2020-004033-20-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
6EUCTR2020-004033-20-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
7EUCTR2020-004033-20-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
8EUCTR2020-004033-20-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
9EUCTR2020-004033-20-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
10EUCTR2020-004033-20-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
11EUCTR2020-004032-21-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
12EUCTR2020-004032-21-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
13EUCTR2020-004032-21-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
14EUCTR2020-004032-21-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
15EUCTR2020-004032-21-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
16JPRN-jRCT2071210025
25/05/202124/05/2021A 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 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 ThrombocytopeniaPatients will receive ARGX-113 PH20 SC (1000 mg of Efgartigimod Alfa) or placebo PH20 SC, weekly from visits 1 to 4 and then from visits 5 to 16 either weekly or biweekly, adjusted according to their platelet count. From visits 17 to 24, patients will be fixed on the dosing schedule they were receiving at visit 16 or the last visit at which IMP was administered (i.e. either weekly or biweekly).Gandini DomenicaNULLNot Recruiting>= 20age oldNot applicableBoth9Phase 3Argentina;Australia;Bulgaria;Chile;China;Colombia;Denmark;France;Georgia;Germany;Greece;Ireland;Israel;Italy;Jordan;Republic of Korea;Latvia;Mexico;New Zealand;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;United Kingdom;United State;Japan
17EUCTR2020-004032-21-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
18EUCTR2020-004032-21-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
19EUCTR2019-002101-21-AT
(EUCTR)
22/03/202124/11/2020A 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
argenx BVNULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Georgia;Netherlands;Germany;Japan
20EUCTR2019-002101-21-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
21EUCTR2019-002101-21-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 BVNULLNot RecruitingFemale: yes
Male: yes
156Phase 3Georgia;Bulgaria;Netherlands;United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Germany;Japan
22NCT04687072
(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
23EUCTR2019-002101-21-PL
(EUCTR)
09/12/202015/07/2021A 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
argenx BVNULLAuthorised-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;Poland;Belgium;Bulgaria;Georgia;Netherlands;Germany;Japan
24NCT04274452
(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
25NCT04225156
(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: efgartigimodargenxNULLActive, not recruiting18 YearsN/AAll101Phase 3United States;Austria;Belgium;Bulgaria;Czechia;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Turkey;Ukraine;United Kingdom
26EUCTR2019-002101-21-NL
(EUCTR)
25/05/202007/01/2020A 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+ 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 BVNULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan
27EUCTR2019-002101-21-IT
(EUCTR)
18/05/202017/06/2021A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorderthat 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 BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Germany;Netherlands;Japan
28EUCTR2019-002101-21-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 BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan
29EUCTR2019-002101-21-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 BVNULLAuthorised-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;Poland;Belgium;Bulgaria;Georgia;Netherlands;Germany;Japan
30EUCTR2019-002100-41-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] - Blood and lymphatic diseases [C15]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alpha
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan
31EUCTR2019-002101-21-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
argenx BVNULLAuthorised-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;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan
32EUCTR2019-002101-21-FR
(EUCTR)
22/04/202020/02/2020A 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+ 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 BVBANULLNot RecruitingFemale: 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
33EUCTR2019-002100-41-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] - Blood and lymphatic diseases [C15]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alpha
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
34EUCTR2019-002101-21-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
35EUCTR2019-002101-21-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
36EUCTR2019-002100-41-CZ
(EUCTR)
20/02/202008/11/2019A 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]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: 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
37EUCTR2019-002100-41-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: 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: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Georgia;Netherlands;Germany;Japan
38EUCTR2019-002100-41-IT
(EUCTR)
07/02/202018/06/2021A 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 BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan
39EUCTR2019-002100-41-FR
(EUCTR)
04/02/202028/10/2019A 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]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: 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
40EUCTR2019-002100-41-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] - Blood and lymphatic diseases [C15]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan
41EUCTR2019-002100-41-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
42EUCTR2019-002100-41-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: 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: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD alfa
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan
43EUCTR2019-002100-41-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]
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 finished Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan
44NCT04188379
(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: PlaceboargenxNULLCompleted18 YearsN/AAll131Phase 3United States;Austria;Belgium;Bulgaria;Czechia;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Turkey;Ukraine;United Kingdom
45EUCTR2019-002100-41-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 - 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 ALFA
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
156Phase 3United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan
46EUCTR2019-000361-21-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
47EUCTR2020-004032-21-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