109. 非典型溶血性尿毒症症候群 Atypical hemolytic uremic syndrome Clinical trials / Disease details
臨床試験数 : 115 / 薬物数 : 37 - (DrugBank : 7) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 10
| 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 | EUCTR2020-002437-15-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 PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) | 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] | 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 | 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 | ||
| 2 | JPRN-jRCT2041210086 | 24/12/2021 | 18/10/2021 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS) | 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) | 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 |
| 3 | 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 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 | 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] | 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 | 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 | ||
| 4 | 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 PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) | 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] | 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 | 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 | ||
| 5 | NCT04958265 (ClinicalTrials.gov) | November 16, 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 Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Pediatric Patients With Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome | Drug: Crovalimab | Hoffmann-La Roche | Chugai Pharmaceutical | Recruiting | N/A | 17 Years | All | 35 | Phase 3 | United States;Canada;China;France;Italy;Japan;Poland;Belgium;Brazil;Hungary;Israel;South Africa;Spain |
| 6 | 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 PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) | 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] | 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 | 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 | ||
| 7 | 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 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) | 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;Poland;South Africa;Spain;Turkey;Peru |
| 8 | 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 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) | 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] | 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 | Roche Farma S. A. que realiza el ensayo en España y que actúa como representante 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 | ||
| 9 | 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 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) | 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] | Product Name: crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: crovalimab 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 | 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 | ||
| 10 | EUCTR2020-002475-35-IT (EUCTR) | 15/06/2021 | 07/06/2021 | A Study Evaluating the Efficacy and Safety 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 PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) - COMMUTE-a | 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] | Product Name: crovalimab Product Code: [RO7112689/F03-10] INN or Proposed INN: crovalimab 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 | 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 | ||
| 11 | EUCTR2020-002475-35-DE (EUCTR) | 08/06/2021 | 19/03/2021 | A Study Evaluating the Efficacy and Safety 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 PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) | 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] | Product Name: crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: crovalimab 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 | 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 | ||
| 12 | EUCTR2020-002475-35-PL (EUCTR) | 20/05/2021 | 21/04/2021 | A Study Evaluating the Efficacy and Safety 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 PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) | 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] | Product Name: crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: crovalimab 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 | 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 | ||
| 13 | JPRN-jRCT2031210061 | 20/05/2021 | 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 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) | 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 |
| 14 | EUCTR2020-002475-35-BE (EUCTR) | 19/03/2021 | A Study Evaluating the Efficacy and Safety 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 PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) | 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] | Product Name: crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: crovalimab Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Spain;Turkey;Luxembourg;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;Peru;South Africa;Germany;China;Korea, Republic of | |||
| 15 | EUCTR2020-002437-15-BE (EUCTR) | 03/09/2021 | A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB IN ADOLESCENT AND PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) | 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] | 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 | F.Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 35 | Phase 3 | United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japan |