109. 非典型溶血性尿毒症症候群 [臨床試験数:95,薬物数:27(DrugBank:5),標的遺伝子数:2,標的パスウェイ数:9

Searched query = "Atypical hemolytic uremic syndrome", "aHUS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
59 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03999840January 202125/6/2019Eculizumab to Cemdisiran Switch in aHUSA Phase II, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Cemdisiran (ALN-CC5) Following Withdrawal of Chronic Eculizumab Therapy in Patients With Atypical HUS at High Risk of RecurrenceAtypical Hemolytic Uremic SyndromeDrug: cemdisiran;Drug: PlacebosMario Negri Institute for Pharmacological ResearchAlnylam PharmaceuticalsNot yet recruiting12 YearsN/AAll12Phase 2Italy
2EUCTR2019-001619-21-ES07/10/201911/06/2019OPTIMIZATION OF MAINTENANCE DOSE WITH ECULIZUMAB ACCORDING TO WEIGHT IN PATIENTS WITH ATYPIC HAEMOLITHIC URINE MUSCLE SYNDROMEPILOT STUDY FOR THE OPTIMITZATION OF THE MAINTENANCE DOSE OF ECULIZUMAB ACCORDING TO THE WEIGHT IN ADULT PATIENTS WITH ATYPIC HEMOLYTIC UREMIC SYNDROME - OPTIMAB ATYPICAL HEMOLYTIC UREMIC SYNDROME
MedDRA version: 20.1 Level: LLT Classification code 10079841 Term: Atypical hemolytic uremic syndrome System Organ Class: 100000004851 ;Therapeutic area: Not possible to specify
HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesSpain
3NCT03518203August 3, 20185/3/2018Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant RecipientsEarly Intervention With Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome (TMA/aHUS)-Associated Multiple Organ Dysfunction Syndrome (MODS) in Hematopoietic Stem Cell Transplant (HCT) RecipientsThrombotic Microangiopathies;Atypical Hemolytic Uremic Syndrome;Multiple Organ Dysfunction SyndromeDrug: EculizumabChildren's Hospital Medical Center, CincinnatiNULLRecruitingN/AN/AAll21Phase 2United States
4EUCTR2017-003916-37-GB13/04/201819/02/2018Stopping Eculizumab Treatment Safely in atypical Haemolytic Uraemic Syndrome (SETS aHUS)Multicentre, open label, prospective, single arm study of the safety and impact of eculizumab withdrawal in patients with atypical haemolytic uraemic syndrome - SETS aHUS: Stopping Eculizumab Treatment Safely in aHUS Atypical Haemolytic Uraemic Syndrome (aHUS);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Newcastle Upon Tyne Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited Kingdom
5EUCTR2015-003135-35-DE20/06/201608/02/2016EVALUATION OF POTENTIAL PREDICTORS OF DISEASE PROGRESSION IN PATIENTS WITH aHUS, INCLUDING GENETICS, BIOMARKERS, ANDTREATMENTEVALUATION OF POTENTIAL PREDICTORS OF DISEASE PROGRESSION IN PATIENTS WITH aHUS, INCLUDING GENETICS, BIOMARKERS, ANDTREATMENT - EVIDENCE atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 19.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: SOLIRIS
Product Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
330Phase 4United Arab Emirates;United States;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02614898November 4, 201524/11/2015Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and TreatmentEvidence - Evaluation of Potential Predictors of Disease Progression in Patients With aHUS, Including Genetics, Biomarkers and TreatmentAtypical Hemolytic Uremic SyndromeOther: EculizumabAlexion PharmaceuticalsNULLTerminatedN/AN/AAll67United States;Australia;Germany;United Kingdom
7NCT02574403November 20155/10/2015Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUSMulticentric, Prospective Open-label Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic SyndromeDrug: eculizumabNantes University HospitalNULLCompleted3 YearsN/AAll58Phase 4France
8EUCTR2010-020326-18-FR25/03/201321/09/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROMEAN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 12.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom
9NCT01757431May 16, 20124/12/2012The Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic Syndrome (aHUS)Drug: EculizumabAlexion PharmaceuticalsNULLCompletedN/AN/AAll2Phase 2Japan
10EUCTR2010-020310-28-BE09/11/201116/08/2011-AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) - Not Applicable Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.0Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15United States;Canada;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2010-020310-28-ES07/11/201108/09/2011-AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) - - Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.0Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15United Kingdom;Canada;Netherlands;Belgium;Spain;Italy;United States;Austria;Australia
12EUCTR2010-020310-28-NL07/07/201120/10/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 12.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15United Kingdom;Netherlands;Belgium;Spain;Italy;Austria
13EUCTR2010-020326-18-NL04/03/201119/10/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROMEAN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 12.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
30France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom
14EUCTR2010-020310-28-GB01/02/201121/10/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.1 Level: LLT Classification code 10019515 Term: Hemolytic uremic syndrome System Organ Class: 100000004851
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
15EUCTR2010-020326-18-BE20/01/201127/09/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROMEAN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 13.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2010-020310-28-DE17/01/201120/10/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
20Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom
17EUCTR2010-020326-18-IT14/01/201117/12/2010An open-label, multi-center clinical trial of eculizumab in adult patients with atypical hemolytic-uremic syndrome - NDAn open-label, multi-center clinical trial of eculizumab in adult patients with atypical hemolytic-uremic syndrome - ND Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10019515
Trade Name: SOLIRISALEXION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
30France;Spain;Belgium;Netherlands;Germany;United Kingdom;Italy
18EUCTR2010-020310-28-IT14/01/201103/02/2011An open-label, multi-center clinical trial of eculizumab in pediatric patients with atypical hemolytic-uremic syndrome (aHUS) - NDAn open-label, multi-center clinical trial of eculizumab in pediatric patients with atypical hemolytic-uremic syndrome (aHUS) - ND Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10019515
INN or Proposed INN: eculizumabALEXION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
15Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Italy
19EUCTR2010-020326-18-ES12/01/201118/10/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROMEAN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME pacientes adultos con síndrome hemolítico urémico atípico; Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS):
MedDRA version: 12.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndrome
Trade Name: SOLIRIS 300 mg concentrado para solución para perfusión
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ECULIZUMAB
ALEXION PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Germany;United Kingdom;Netherlands;Belgium;Spain;Italy
20EUCTR2010-020310-28-AT16/12/201008/11/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.0Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2010-020326-18-DE26/11/201006/09/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROMEAN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 14.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 100000004851
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
60Spain;Belgium;Netherlands;Germany;Italy;United Kingdom
22EUCTR2010-020326-18-GB19/10/201026/08/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROMEAN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 14.0Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
60France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom
23NCT01193348September 201031/8/2010An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic SyndromeAn Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic SyndromeAtypical Hemolytic-Uremic SyndromeDrug: EculizumabAlexion PharmaceuticalsNULLCompleted1 Month18 YearsAll22Phase 2United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;United Kingdom
24NCT01194973July 201031/8/2010An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic SyndromeAn Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic SyndromeAtypical Hemolytic-Uremic SyndromeDrug: EculizumabAlexion PharmaceuticalsNULLCompleted18 YearsN/AAll44Phase 2United States;Belgium;France;Germany;Italy;Spain;United Kingdom
25EUCTR2008-006952-23-DE19/08/200919/02/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
8France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2008-006955-28-DE19/08/200919/02/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age weighing = 40 kg) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
27EUCTR2008-006953-41-DE19/08/200919/02/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age weighing = 40 kg) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
7Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
28EUCTR2008-006955-28-NL12/08/200926/02/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
29EUCTR2008-006954-17-NL12/08/200926/02/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15France;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
30EUCTR2008-006952-23-NL05/08/200926/02/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
8France;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2008-006953-41-NL05/08/200926/02/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
7Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
32NCT00838513July 20093/2/2009Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS)An Open-label, Multi-center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (AHUS)Atypical Hemolytic Uremic SyndromeDrug: eculizumabAlexion PharmaceuticalsNULLCompleted18 YearsN/AAll15Phase 2Canada;France;Germany;Italy;Netherlands;Sweden;United Kingdom;Austria;Spain;Switzerland;United States
33NCT00844428July 200912/2/2009Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUSAn Open-Label, Multi-Center Controlled Clinical Trial Of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive Atypical Hemolytic Uremic Syndrome (AHUS)Atypical Hemolytic Uremic SyndromeDrug: eculizumabAlexion PharmaceuticalsNULLCompleted12 Years17 YearsAll5Phase 2Canada;France;Germany;Italy;Netherlands;Sweden;United Kingdom;Austria;Spain;Switzerland;United States
34EUCTR2008-006954-17-DE18/06/200919/02/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
35EUCTR2008-006954-17-ES10/06/200908/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO, DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADULTOS CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUa) QUE RESPONDE A PLASMOTERAPIAAN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO, DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADULTOS CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUa) QUE RESPONDE A PLASMOTERAPIA Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)Pacientes adultos con síndrome hemolítico urémico atípico (SHUa) que responde a plasmoterapia
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS 300 mg concentrado para solución para perfusión
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ECULIZUMAB
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2008-006955-28-AT10/06/200918/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
37EUCTR2008-006952-23-AT10/06/200918/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
8France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
38EUCTR2008-006954-17-AT10/06/200918/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
39EUCTR2008-006952-23-ES10/06/200907/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADULTOS CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUa) RESISTENTE A LA PLASMOTERAPIAAN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADULTOS CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUa) RESISTENTE A LA PLASMOTERAPIA Adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS)Pacientes adultos con síndrome hemolítico urémico atípico (SHUa) resistente a la plasmoterapia
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS 300 mg concentrado para solución para perfusión
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ECULIZUMAB
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
8United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden
40EUCTR2008-006953-41-AT10/06/200918/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
7Phase 2Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2008-006955-28-ES10/06/200908/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADOLESCENTES CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUA) QUE RESPONDE A PLASMOTERAPIAAN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADOLESCENTES CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUA) QUE RESPONDE A PLASMOTERAPIA Adolescent patients (from 12 and up to 18 years of age) with plasma therapy sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).Pacientes adolescentes (de 12 a 18 años) con síndrome hemolítico urémico atípico (SHUa) que responde a plasmoterapia
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS 300 mg concentrado para solución para perfusión
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ECULIZUMAB
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15United Kingdom;Germany;Netherlands;Spain;Italy;Austria;Sweden
42EUCTR2008-006953-41-IT04/06/200911/12/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPYRESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) - NDAN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPYRESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) - ND Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 12.1Level: LLTClassification code 10018933Term: Haemolytic-uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: Eculizumab
ALEXION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
7Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
43EUCTR2008-006952-23-IT04/06/200911/12/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) - NDAN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) - ND Adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 12.1Level: LLTClassification code 10018933Term: Haemolytic-uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: Eculizumab
ALEXION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
8France;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
44EUCTR2008-006955-28-IT04/06/200911/12/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPYSENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) - NDAN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPYSENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) - ND Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 12.1Level: LLTClassification code 10018933Term: Haemolytic-uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: Eculizumab
ALEXION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
15Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
45EUCTR2008-006954-17-IT04/06/200911/12/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) - NDAN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) - ND Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 12.1Level: LLTClassification code 10018933Term: Haemolytic-uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: Eculizumab
ALEXION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
15France;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2008-006954-17-GB28/05/200915/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.1 Level: PT Classification code 10018932 Term: Haemolytic uraemic syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
47EUCTR2008-006953-41-GB28/05/200914/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1 Level: LLT Classification code 10018932 Term: Haemolytic uraemic syndrome
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
7 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noAustria;Netherlands;Germany;Italy;United Kingdom;Sweden
48EUCTR2008-006955-28-GB28/05/200914/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1 Level: LLT Classification code 10018932 Term: Haemolytic uraemic syndrome
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSpain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
49EUCTR2008-006952-23-GB28/05/200915/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 9.1 Level: LLT Classification code 10018932 Term: Haemolytic uraemic syndrome
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
8 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
50NCT00844844May 200913/2/2009Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUSAn Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic SyndromeDrug: EculizumabAlexion PharmaceuticalsNULLCompleted12 Years17 YearsAll1Phase 2United States;Austria;France;Germany;United Kingdom;Canada;Italy;Netherlands;Spain;Sweden;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT00844545May 200913/2/2009Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUSAn Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic SyndromeDrug: EculizumabAlexion PharmaceuticalsNULLCompleted18 YearsN/AAll16Phase 2United States;Austria;France;Germany;United Kingdom;Italy;Netherlands;Spain;Sweden;Switzerland
52EUCTR2008-006955-28-SE15/04/200904/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
53EUCTR2008-006954-17-SE15/04/200904/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
54EUCTR2008-006953-41-SE15/04/200904/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
7Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
55EUCTR2008-006952-23-SE15/04/200904/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
8France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2008-006952-23-FR09/04/200919/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
8United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden
57EUCTR2008-006954-17-FR09/04/200919/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 9.1Level: LLTClassification code 10018932Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden
58EUCTR2010-020310-28-FR05/11/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 12.1Level: LLTClassification code 10019515Term: Hemolytic uremic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15Phase 2France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
59EUCTR2015-003135-35-IT20/04/2018EVIDENCE - EVALUATION OF POTENTIAL PREDICTORS OF DISEASE PROGRESSION IN PATIENTS WITH aHUS, INCLUDING GENETICS, BIOMARKERS, AND TREATMENTEVIDENCE - EVALUATION OF POTENTIAL PREDICTORS OF DISEASE PROGRESSION IN PATIENTS WITH aHUS, INCLUDING GENETICS, BIOMARKERS, AND TREATMENT - EVIDENCE atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 20.0Level: LLTClassification code 10019515Term: Hemolytic uremic syndromeSystem Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML)
INN or Proposed INN: Eculizumab
Other descriptive name: /
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
330Phase 4United Arab Emirates;United States;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Norway