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

  
5 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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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-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
3EUCTR2020-002437-15-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
4EUCTR2020-002437-15-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
5EUCTR2020-002437-15-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