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
| 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 | NCT05653349 (ClinicalTrials.gov) | March 31, 2023 | 23/11/2022 | Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) | A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1) | Primary Immune Thrombocytopenia (ITP) | Biological: Ianalumab;Drug: Placebo;Drug: Corticosteroids | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 225 | Phase 3 | Belgium;Hungary;Romania;Singapore;Spain;United Kingdom |
| 2 | NCT05653219 (ClinicalTrials.gov) | February 2, 2023 | 23/11/2022 | A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids | A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2) | Primary Immune Thrombocytopenia | Biological: Ianalumab;Drug: Eltrombopag;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | Czechia;Hungary;Korea, Republic of;Singapore;United Kingdom |
| 3 | EUCTR2022-001627-32-ES (EUCTR) | 23/01/2023 | 01/11/2022 | A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids | A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2) - VAYHIT2 | immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Philippines;Taiwan;Thailand;Spain;Italy;India;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Singapore;Romania;Germany;Norway;Japan | ||
| 4 | EUCTR2022-001627-32-NL (EUCTR) | 29/12/2022 | 31/10/2022 | A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids | A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2) - VAYHIT2 | immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Philippines;Taiwan;Thailand;Spain;Italy;India;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Singapore;Romania;Germany;Norway;Japan | ||
| 5 | EUCTR2022-001672-34-ES (EUCTR) | 23/12/2022 | 11/10/2022 | A study of ianalumab (VAY736) in addition to first-line corticosteroids in patients with primary immune thrombocytopenia | A phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (VAYHIT1) | Primary Immune thrombocytopenia (ITP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Czechia;Hong Kong;Spain;Thailand;Turkey;Austria;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Malaysia;Singapore;Romania;Viet Nam;Australia;Germany;China;Japan | ||
| 6 | EUCTR2022-001627-32-CZ (EUCTR) | 05/12/2022 | 20/10/2022 | A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids | A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2) - VAYHIT2 | immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Singapore;United States;Czechia;Malaysia;Thailand;Austria;Netherlands;China;Korea, Republic of;France;Romania;Hungary;Japan;Philippines;United Kingdom;India;Spain;Czech Republic;Turkey;Belgium;Norway;Taiwan;Mexico;Italy;Australia;Germany |