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 : 363 / 薬物数 : 212 - (DrugBank : 43) / 標的遺伝子数 : 47 - 標的パスウェイ数 : 138
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-004032-21-DK (EUCTR) | 11/01/2022 | 16/04/2021 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 2 | EUCTR2020-004033-20-NO (EUCTR) | 08/09/2021 | 20/04/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 3 | EUCTR2020-004033-20-GR (EUCTR) | 07/09/2021 | 19/07/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 4 | EUCTR2020-004033-20-BG (EUCTR) | 03/09/2021 | 26/05/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 5 | EUCTR2020-004033-20-PT (EUCTR) | 03/09/2021 | 20/05/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 6 | EUCTR2020-004033-20-ES (EUCTR) | 13/08/2021 | 09/06/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 7 | EUCTR2020-004033-20-IT (EUCTR) | 23/07/2021 | 17/08/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 8 | EUCTR2020-004032-21-PT (EUCTR) | 19/07/2021 | 11/03/2021 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 9 | EUCTR2020-004032-21-NO (EUCTR) | 25/06/2021 | 18/03/2021 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United 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 | ||
| 10 | EUCTR2020-004032-21-DE (EUCTR) | 15/06/2021 | 12/03/2021 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 11 | EUCTR2020-004032-21-IT (EUCTR) | 04/06/2021 | 08/06/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH20 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: 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 12 | JPRN-jRCT2071210025 | 25/05/2021 | 24/05/2021 | 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 | 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 | Patients 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 Domenica | NULL | Recruiting | >= 20age old | Not applicable | Both | 9 | Phase 3 | 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;Argentina;Australia;Bulgaria;Chile;China;Colombia |
| 13 | EUCTR2020-004032-21-BG (EUCTR) | 17/05/2021 | 15/03/2021 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;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 | ||
| 14 | EUCTR2020-004032-21-IE (EUCTR) | 07/05/2021 | 17/02/2021 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Portugal;Serbia;Taiwan;Greece;Spain;Thailand;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 15 | EUCTR2019-002101-21-FR (EUCTR) | 22/04/2020 | 20/02/2020 | 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+ | 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan | ||
| 16 | EUCTR2019-002101-21-ES (EUCTR) | 09/04/2020 | 23/01/2020 | A 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan | ||
| 17 | EUCTR2019-002100-41-CZ (EUCTR) | 20/02/2020 | 08/11/2019 | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan | ||
| 18 | EUCTR2019-002100-41-FR (EUCTR) | 04/02/2020 | 28/10/2019 | A 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 BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan | ||
| 19 | EUCTR2019-002100-41-BE (EUCTR) | 10/01/2020 | 21/11/2019 | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | Japan;Germany;Netherlands;Bulgaria;Georgia;Belgium;Poland;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Austria;Turkey;Ukraine;Spain;Czechia;United States | ||
| 20 | EUCTR2019-002100-41-HU (EUCTR) | 17/12/2019 | 30/10/2019 | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan | ||
| 21 | EUCTR2019-002100-41-ES (EUCTR) | 16/12/2019 | 11/11/2019 | A 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 BVBA | NULL | Authorised-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): no | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan | ||
| 22 | EUCTR2019-002100-41-NL (EUCTR) | 01/11/2019 | 07/08/2019 | A 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 BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan | ||
| 23 | EUCTR2020-004032-21-GR (EUCTR) | 19/04/2021 | A 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan |