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 : 114 薬物数 : 36 - (DrugBank : 7) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 11

  
11 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002437-15-HU
(EUCTR)
18/01/202206/12/2021A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japan
2EUCTR2020-002437-15-IT
(EUCTR)
21/12/202126/01/2022A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japan
3EUCTR2020-002437-15-PL
(EUCTR)
08/12/202104/10/2021A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Poland;Brazil;Belgium;South Africa;China;Japan
4EUCTR2020-002437-15-FR
(EUCTR)
28/10/202102/09/2021A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Brazil;Belgium;Poland;South Africa;China;Japan
5EUCTR2020-002437-15-ES
(EUCTR)
23/09/202123/07/2021A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Brazil;Belgium;Poland;South Africa;China;Japan
6EUCTR2020-002475-35-FR
(EUCTR)
06/08/202122/06/2021A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
7EUCTR2020-002475-35-IT
(EUCTR)
15/06/202107/06/2021A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
8EUCTR2020-002475-35-DE
(EUCTR)
08/06/202119/03/2021A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
9EUCTR2020-002475-35-PL
(EUCTR)
20/05/202121/04/2021A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
10EUCTR2020-002475-35-BE
(EUCTR)
19/03/2021A 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 LtdNULLNAFemale: yes
Male: yes
90Phase 3United 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
11EUCTR2020-002437-15-BE
(EUCTR)
03/09/2021A 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 LtdNULLNAFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japan