CROVALIMAB ( DrugBank: Crovalimab )
2 diseases
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
62 | 発作性夜間ヘモグロビン尿症 | 30 |
109 | 非典型溶血性尿毒症症候群 | 15 |
62. 発作性夜間ヘモグロビン尿症
臨床試験数 : 292 / 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
Showing 1 to 10 of 30 diseases
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 | EUCTR2019-004931-21-RO (EUCTR) | 14/02/2022 | 19/05/2022 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors A Study to Evaluate the Efficacy and Safety of Crovalimabversus Eculizumab in Adult and Adolescent P ... | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AN ... | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ... | Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Sol ... | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Germany;Japan;Sweden Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Col ... | ||
2 | EUCTR2020-000597-26-IE (EUCTR) | 23/09/2021 | 13/01/2021 | A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and efficacy of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors. A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and efficacy of Crovalimabversus ... | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, PHA ... | PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Sol ... | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Thailand;Spain;Ireland;Israel;Col ... | ||
3 | EUCTR2019-004931-21-LT (EUCTR) | 15/07/2021 | 19/05/2021 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors A Study to Evaluate the Efficacy and Safety of Crovalimabversus Eculizumab in Adult and Adolescent P ... | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AN ... | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ... | Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Sol ... | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Germany;Japan;Sweden Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Col ... | ||
4 | EUCTR2019-004931-21-EE (EUCTR) | 30/06/2021 | 24/04/2021 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors A Study to Evaluate the Efficacy and Safety of Crovalimabversus Eculizumab in Adult and Adolescent P ... | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AN ... | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ... | Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Sol ... | F. Hoffman-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;United States;Philippines;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Germany;Japan;Sweden Portugal;United States;Philippines;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Col ... | ||
5 | EUCTR2020-000597-26-EE (EUCTR) | 30/06/2021 | 24/04/2021 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors. A Study to Evaluate the Efficacy and Safety of Crovalimabversus Eculizumab in Adult and Adolescent P ... | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SA ... | PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Sol ... | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Germany;Japan;Sweden Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Spain;Thailand;Ireland;Israel;Col ... | ||
6 | EUCTR2019-004931-21-PT (EUCTR) | 19/05/2021 | 28/10/2020 | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AN ... | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AN ... | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ... | Trade Name: Soliris 300 mg concentrate for solution for infusion INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Trade Name: Soliris 300 mg concentrate for solution for infusion INN or Proposed INN: ECULIZUMAB Produ ... | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Japan;Sweden United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Spain;Thailand;Ireland;Israel;Col ... | ||
7 | EUCTR2020-000597-26-PT (EUCTR) | 18/05/2021 | 23/12/2020 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors. A Study to Evaluate the Efficacy and Safety of Crovalimabversus Eculizumab in Adult and Adolescent P ... | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SA ... | PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: SOLIRIS® (eculizumab) injection, for intravenous use Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: SOLIRIS® ( ... | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden Portugal;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy; ... | ||
8 | EUCTR2020-000597-26-CZ (EUCTR) | 28/04/2021 | 22/12/2020 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors. A Study to Evaluate the Efficacy and Safety of Crovalimabversus Eculizumab in Adult and Adolescent P ... | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SA ... | PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Sol ... | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Germany;Japan;Sweden Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Spain;Thailand;Ireland;Israel;Col ... | ||
9 | NCT04654468 (ClinicalTrials.gov) | March 17, 2021 | 30/11/2020 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimabin Parti ... | A Phase III, Multicenter, Single Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition A Phase III, Multicenter, Single Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Ph ... | Paroxysmal Nocturnal Hemoglobinuria | Drug: Crovalimab | Hoffmann-La Roche | NULL | Active, not recruiting | 12 Years | N/A | All | 51 | Phase 3 | China |
10 | EUCTR2019-004931-21-FR (EUCTR) | 26/01/2021 | 18/09/2020 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors A Study to Evaluate the Efficacy and Safety of Crovalimabversus Eculizumab in Adult and Adolescent P ... | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AN ... | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ... | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Pro ... | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;Sweden United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia; ... |
109. 非典型溶血性尿毒症症候群
臨床試験数 : 114 / 薬物数 : 36 - (DrugBank : 7) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 11
Showing 1 to 10 of 15 diseases
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 | JPRN-jRCT2041210086 | 28/07/2022 | 18/10/2021 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimabin Pedia ... | A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PH ... | Atypical Hemolytic Uremic Syndrome | RO7112689 (crovalimab): Intravenous and Subcutaneous | Mona D. Shah | NULL | Recruiting | Not applicable | <= 17age old | Both | 35 | Phase 3 | Belgium;Brazil;Canada;France;Hungary;Israel;Italy;China;Poland;South Africa;Spain;United States;Japan Belgium;Brazil;Canada;France;Hungary;Israel;Italy;China;Poland;South Africa;Spain;United States;Japa ... |
2 | JPRN-jRCT2031210061 | 10/05/2022 | 27/04/2021 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants with Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimabin Adult ... | A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Ph ... | Atypical Hemolytic Uremic Syndrome | RO7112689 (crovalimab): Intravenous and Subcutaneous | Camelia Sima | NULL | Recruiting | >= 12age old | Not applicable | Both | 90 | Phase 3 | CANADA;BELGIUM;FRANCE;UNITED STATES;BRAZIL;POLAND;MEXICO;GERMANY;CHINA;Japan |
3 | EUCTR2020-002437-15-HU (EUCTR) | 18/01/2022 | 06/12/2021 | A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy and Safety of Crovalimabin Pediatric Patients with Atypical Hemolyti ... | A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PH ... | Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 100798 ... | Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Other descripti ... | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Phase 3 | United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japan United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japa ... | ||
4 | EUCTR2020-002437-15-IT (EUCTR) | 21/12/2021 | 26/01/2022 | A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy and Safety of Crovalimabin Pediatric Patients with Atypical Hemolyti ... | A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) - na A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PH ... | Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 100798 ... | Product Name: Crovalimab Product Code: [RO7112689/F03-10] INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: [RO7112689/F03-01] INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: [RO7112689/F03-10] INN or Proposed INN: CROVALIMAB Other descrip ... | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Phase 3 | United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japan United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japa ... | ||
5 | EUCTR2020-002437-15-PL (EUCTR) | 08/12/2021 | 04/10/2021 | A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy and Safety of Crovalimabin Pediatric Patients with Atypical Hemolyti ... | A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PH ... | Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 100798 ... | Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Other descripti ... | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Phase 3 | United States;Spain;Israel;Italy;France;Hungary;Canada;Poland;Brazil;Belgium;South Africa;China;Japan United States;Spain;Israel;Italy;France;Hungary;Canada;Poland;Brazil;Belgium;South Africa;China;Japa ... | ||
6 | NCT04958265 (ClinicalTrials.gov) | November 17, 2021 | 6/7/2021 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimabin Pedia ... | A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Pediatric Patients With Atypical Hemolytic Uremic Syndrome (aHUS) A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Ph ... | Atypical Hemolytic Uremic Syndrome | Drug: Crovalimab | Hoffmann-La Roche | Chugai Pharmaceutical | Recruiting | 28 Days | 17 Years | All | 35 | Phase 3 | United States;Belgium;Brazil;Canada;China;France;Israel;Italy;Japan;Poland;South Africa;Spain;Hungary United States;Belgium;Brazil;Canada;China;France;Israel;Italy;Japan;Poland;South Africa;Spain;Hungar ... |
7 | EUCTR2020-002437-15-FR (EUCTR) | 28/10/2021 | 02/09/2021 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimabin Pedia ... | A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PH ... | Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 100798 ... | Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Other descripti ... | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Phase 3 | United States;Spain;Israel;Italy;France;Hungary;Canada;Brazil;Belgium;Poland;South Africa;China;Japan United States;Spain;Israel;Italy;France;Hungary;Canada;Brazil;Belgium;Poland;South Africa;China;Japa ... | ||
8 | NCT04861259 (ClinicalTrials.gov) | October 22, 2021 | 23/4/2021 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimabin Adult ... | A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS) A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Ph ... | Atypical Hemolytic Uremic Syndrome | Drug: Crovalimab | Hoffmann-La Roche | Chugai Pharmaceutical | Recruiting | 12 Years | N/A | All | 90 | Phase 3 | United States;Belgium;Brazil;Canada;China;France;Germany;Hungary;Israel;Italy;Japan;Mexico;Peru;Poland;South Africa;Spain;Turkey United States;Belgium;Brazil;Canada;China;France;Germany;Hungary;Israel;Italy;Japan;Mexico;Peru;Pola ... |
9 | EUCTR2020-002437-15-ES (EUCTR) | 23/09/2021 | 23/07/2021 | A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy and Safety of Crovalimabin Pediatric Patients with Atypical Hemolyti ... | A PHASE III, OPEN-LABEL, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB IN ADOLESCENT AND PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) A PHASE III, OPEN-LABEL, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALI ... | Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 100798 ... | Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB Other descripti ... | Roche Farma S. A. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd Roche Farma S. A. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roch ... | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Phase 3 | United States;Spain;Israel;Italy;France;Hungary;Canada;Brazil;Belgium;Poland;South Africa;China;Japan United States;Spain;Israel;Italy;France;Hungary;Canada;Brazil;Belgium;Poland;South Africa;China;Japa ... | ||
10 | EUCTR2020-002475-35-FR (EUCTR) | 06/08/2021 | 22/06/2021 | A Study Evaluating the Efficacy and Safety of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) A Study Evaluating the Efficacy and Safety of Crovalimabin Adult and Adolescent Patients with Atypic ... | A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PH ... | Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.1;Level: LLT;Classification code 100798 ... | Product Name: crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: crovalimab Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Name: crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: crovalimab Other descripti ... | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Spain;Turkey;Luxembourg;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;Peru;South Africa;Germany;China;Korea, Republic of United States;Czechia;Spain;Turkey;Luxembourg;Israel;United Kingdom;Italy;France;Hungary;Mexico;Cana ... |