62. 発作性夜間ヘモグロビン尿症 Paroxysmal nocturnal hemoglobinuria Clinical trials / Disease details
臨床試験数 : 271 / 薬物数 : 163 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 106
| 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-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 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 | 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] | 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 | 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 | ||
| 2 | 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 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 | 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] | 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 | 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 | ||
| 3 | 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 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 | 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] | 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 | 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;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;Poland;Brazil;Belgium;Romania;Germany;Japan;Sweden | ||
| 4 | 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 AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS | 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] | 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 | 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 | ||
| 5 | 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 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 | 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] | 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 | 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 | ||
| 6 | 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 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 | 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] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Eculizumab Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Brazil;Belgium;Poland;Germany;Japan;Sweden | ||
| 7 | 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 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 | Paroxysmal Nocturnal Hemoglobinuria | Drug: Crovalimab | Hoffmann-La Roche | NULL | Active, not recruiting | 12 Years | N/A | All | 51 | Phase 3 | China |
| 8 | 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 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 | 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] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | 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 | ||
| 9 | EUCTR2019-004931-21-BE (EUCTR) | 22/01/2021 | 23/11/2020 | 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 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 | 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] | 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 | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Philippines;Taiwan;Estonia;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 | ||
| 10 | EUCTR2020-000597-26-BE (EUCTR) | 11/01/2021 | 15/10/2020 | 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 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 | 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] | 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 | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Philippines;Taiwan;Estonia;Hong Kong;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Romania;Germany;Japan;Sweden | ||
| 11 | EUCTR2019-004931-21-IT (EUCTR) | 10/12/2020 | 24/05/2021 | 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 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 - N/A | Paroxysmal Nocturnal Hemoglobinuria (PNH);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Crovalimab Product Code: [RO7112689] INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab Product Code: [NA] INN or Proposed INN: Eculizumab | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Estonia;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;Sweden | ||
| 12 | EUCTR2020-000597-26-IT (EUCTR) | 10/12/2020 | 22/06/2021 | 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 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 - na | 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] | Product Name: crovalimab Product Code: [RO7112689] INN or Proposed INN: crovalimab Trade Name: Eculizumab Product Name: eculizumab Product Code: [na] INN or Proposed INN: eculizumab Other descriptive name: NA | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Brazil;Belgium;Poland;Germany;Japan;Sweden | ||
| 13 | EUCTR2020-000597-26-GR (EUCTR) | 04/12/2020 | 16/10/2020 | 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 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 | 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] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Eculizumab Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Hong Kong;Taiwan;Greece;Spain;Thailand;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden | ||
| 14 | EUCTR2019-004931-21-GR (EUCTR) | 04/12/2020 | 16/10/2020 | 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 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 | 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] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | 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;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden | ||
| 15 | EUCTR2020-000597-26-DE (EUCTR) | 01/12/2020 | 14/07/2020 | A Study to Evaluate the Efficacy and Safety 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 EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS | 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] | 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 | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Sweden;Japan;Germany;Poland;Belgium;Brazil;Mexico;Hungary;Czech Republic;United Kingdom;Turkey;Czechia;Korea, Republic of;Netherlands;Australia;France;Italy;Colombia | ||
| 16 | EUCTR2019-004931-21-DE (EUCTR) | 01/12/2020 | 14/07/2020 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITH COMPLEMENT INHIBITORS | 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] | 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 | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;Sweden | ||
| 17 | EUCTR2019-004931-21-PL (EUCTR) | 24/11/2020 | 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 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 | 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] | 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 | 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;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Germany;Japan;Sweden | ||
| 18 | EUCTR2020-000597-26-PL (EUCTR) | 23/11/2020 | 16/09/2020 | 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 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 | 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] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Eculizumab Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Brazil;Poland;Belgium;Germany;Japan;Sweden | ||
| 19 | EUCTR2019-004931-21-HU (EUCTR) | 05/11/2020 | 08/09/2020 | 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 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 | 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] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 3 | Hungary;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;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;Sweden | ||
| 20 | EUCTR2019-004931-21-SE (EUCTR) | 26/10/2020 | 03/06/2020 | 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 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 | 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] | 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 | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Philippines;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;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 | ||
| 21 | JPRN-JapicCTI-205425 | 08/10/2020 | 21/08/2020 | A Phase III Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors. ( COMMODORE 2 ) | A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors. | Paroxysmal Nocturnal Hemoglobinuria | Intervention name : Crovalimab INN of the intervention : crovalimab Dosage And administration of the intervention : Participants will receive an initial intravenous (IV) loading dose on Week 1 Day 1, followed by 4 weekly crovalimab subcutaneous (SC) doses on Week 1 Day 2, then on Weeks 2, 3 and 4. Maintenance dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter, for a total of at least 24 weeks of study treatment. Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Control intervention name : Eculizumab INN of the control intervention : eculizumab Dosage And administration of the control intervention : Participants will receive initial IV weekly doses for 4 weeks which will be followed by Q2W (every 2 weeks) IV administrations starting on Week 5. Eculizumab will be administered at a dose of 600 mg for the first 4 weeks, followed by maintenance doses of 900 mg starting on Week 5. | Chugai Pharmaceutical Co., Ltd. | NULL | recruiting | BOTH | 200 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa | ||
| 22 | NCT04434092 (ClinicalTrials.gov) | October 8, 2020 | 3/6/2020 | A Phase III Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors. | A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors. | Paroxysmal Nocturnal Hemoglobinuria | Drug: Crovalimab;Drug: Eculizumab | Hoffmann-La Roche | Chugai Pharmaceutical | Recruiting | N/A | N/A | All | 200 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;China;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Italy;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Portugal;Singapore;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Canada;Chile;Colombia;Czechia;Israel;Peru;Romania;Saudi Arabia |
| 23 | NCT04432584 (ClinicalTrials.gov) | September 30, 2020 | 3/6/2020 | A Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors. | A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors. | Paroxysmal Nocturnal Hemoglobinuria | Drug: Crovalimab;Drug: Eculizumab | Hoffmann-La Roche | Chugai Pharmaceutical | Recruiting | N/A | N/A | All | 250 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Singapore;Slovakia;Spain;Sweden;Taiwan;Turkey;United Kingdom;Colombia;Israel;Mexico;Saudi Arabia |
| 24 | JPRN-JapicCTI-205430 | 29/9/2020 | 24/08/2020 | A Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors. (COMMODORE 1) | A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors. | Paroxysmal Nocturnal Hemoglobinuria | Intervention name : Crovalimab INN of the intervention : crovalimab Dosage And administration of the intervention : Participants will receive a loading series of crovalimab comprised of an intravenous (IV) dose on Day 1, followed by weekly crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter for a total of at least 24 weeks of study treatment. Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Control intervention name : Eculizumab INN of the control intervention : eculizumab Dosage And administration of the control intervention : Participants will receive an approved maintenance dose of eculizumab starting on Day 1 and Q2W (every 2 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of study eculizumab treatment, participants will have the option to switch to crovalimab or to discontinue from the study after completion of 10 weeks of safety follow-up. Eculizumab will be administered at a dose of 900 mg every 2 weeks. | Chugai Pharmaceutical Co., Ltd. | NULL | recruiting | BOTH | 250 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania | ||
| 25 | JPRN-JapicCTI-173517 | 17/10/2017 | 17/02/2017 | An adaptive Phase I/II study of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) | An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria | Intervention name : RO7112689 INN of the intervention : Crovalimab Dosage And administration of the intervention : Intravenous and Subcutaneous Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | CHUGAI PHARMACEUTICAL CO., LTD. | NULL | complete | 18 | 75 | BOTH | 44 | Phase 1-2 | Japan, Asia except Japan, Europe |
| 26 | EUCTR2016-002128-10-DE (EUCTR) | 14/03/2017 | 24/10/2016 | A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria | An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of crovalimab in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) | 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] - Blood and lymphatic diseases [C15] | Product Code: RO7112689/F01 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Code: RO7112689/F03-01 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Code: RO7112689/F03-03 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 49 | Phase 1;Phase 2 | France;Hungary;Netherlands;Germany;Italy;Japan;Korea, Republic of | ||
| 27 | NCT03157635 (ClinicalTrials.gov) | November 14, 2016 | 1/11/2016 | Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria | An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Hemoglobinuria, Nocturnal | Drug: Crovalimab;Drug: Placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 75 Years | All | 59 | Phase 1/Phase 2 | France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands |
| 28 | EUCTR2020-000597-26-IE (EUCTR) | 13/01/2021 | 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 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 | 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] | 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 | F.Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;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;Brazil;Belgium;Poland;Singapore;Romania;Germany;Japan;Sweden | |||
| 29 | EUCTR2019-004931-21-IE (EUCTR) | 13/01/2021 | 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 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 | 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] | Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB | F. Hoffman-La Roche Ltd. | NULL | NA | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;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;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden | |||
| 30 | EUCTR2020-000597-26-SE (EUCTR) | 02/06/2020 | 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 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 | 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] | 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 | F.Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;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;Brazil;Belgium;Poland;Singapore;Romania;Germany;Japan;Sweden |