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

  
60 trials found
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PhaseCountries
1NCT03999840
(ClinicalTrials.gov)
January 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 PharmaceuticalsWithdrawn12 YearsN/AAll0Phase 2Italy
2EUCTR2018-004382-13-IT
(EUCTR)
28/11/201925/05/2021Safety and efficacy of Cemdisiran in athypical hemolytic uremic syndromeA 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 RECURRENCE - Eculizumab to Cemdisiran switch in aHUS Atypical Hemolytic Uremic Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ALN-CC5
Product Code: [ALN-62643]
INN or Proposed INN: Cemdisiran
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLNot RecruitingFemale: yes
Male: yes
12Phase 2Italy
3EUCTR2019-001619-21-ES
(EUCTR)
07/10/201911/06/2019OPTIMIZATION 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
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain
4NCT03518203
(ClinicalTrials.gov)
August 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, CincinnatiNULLActive, not recruitingN/AN/AAll23Phase 2United States
5EUCTR2017-003916-37-GB
(EUCTR)
13/04/201819/02/2018Stopping 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]Trade Name: Solaris
Product Name: Solaris
INN or Proposed INN: Eculizumab
Other descriptive name: IgG2/4?
Newcastle Upon Tyne Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
6EUCTR2015-003135-35-DE
(EUCTR)
20/06/201608/02/2016EVALUATION 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: 19.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System 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
7NCT02614898
(ClinicalTrials.gov)
November 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
8NCT02574403
(ClinicalTrials.gov)
November 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
9EUCTR2010-020326-18-FR
(EUCTR)
25/03/201321/09/2010AN 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: 12.1;Level: LLT;Classification code 10019515;Term: 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
30Phase 2France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom
10NCT01757431
(ClinicalTrials.gov)
May 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
11EUCTR2010-020310-28-BE
(EUCTR)
09/11/201116/08/2011-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: 14.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System 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
12EUCTR2010-020310-28-ES
(EUCTR)
07/11/201108/09/2011-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: 14.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System 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
15Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Germany;Netherlands;Italy;United Kingdom
13EUCTR2010-020310-28-NL
(EUCTR)
07/07/201120/10/2010AN 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: 12.1;Level: LLT;Classification code 10019515;Term: 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
14EUCTR2010-020326-18-NL
(EUCTR)
04/03/201119/10/2010AN 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: 12.1;Level: LLT;Classification code 10019515;Term: 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
15EUCTR2010-020310-28-GB
(EUCTR)
01/02/201121/10/2010AN 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
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
16EUCTR2010-020326-18-BE
(EUCTR)
20/01/201127/09/2010AN 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: 13.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System 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
17EUCTR2010-020310-28-DE
(EUCTR)
17/01/201120/10/2010AN 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: 14.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System 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
18EUCTR2010-020326-18-IT
(EUCTR)
14/01/201117/12/2010An 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: 9.1;Level: LLT;Classification code 10019515
Trade Name: SOLIRISALEXION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
30France;Spain;Belgium;Netherlands;Germany;United Kingdom;Italy
19EUCTR2010-020310-28-IT
(EUCTR)
14/01/201103/02/2011An 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: 9.1;Level: LLT;Classification code 10019515
INN or Proposed INN: eculizumabALEXION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
15Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Italy
20EUCTR2010-020326-18-ES
(EUCTR)
12/01/201118/10/2010AN 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: 12.1;Level: LLT;Classification code 10019515;Term: 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.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
21EUCTR2010-020310-28-AT
(EUCTR)
16/12/201008/11/2010AN 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: 14.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System 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
22EUCTR2010-020326-18-DE
(EUCTR)
26/11/201006/09/2010AN 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: 14.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System 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
23EUCTR2010-020326-18-GB
(EUCTR)
19/10/201026/08/2010AN 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: 14.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System 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
24NCT01193348
(ClinicalTrials.gov)
September 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
25NCT01194973
(ClinicalTrials.gov)
July 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
26EUCTR2008-006952-23-DE
(EUCTR)
19/08/200919/02/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
27EUCTR2008-006955-28-DE
(EUCTR)
19/08/200919/02/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
28EUCTR2008-006953-41-DE
(EUCTR)
19/08/200919/02/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
29EUCTR2008-006955-28-NL
(EUCTR)
12/08/200926/02/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
30EUCTR2008-006954-17-NL
(EUCTR)
12/08/200926/02/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
31EUCTR2008-006952-23-NL
(EUCTR)
05/08/200926/02/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
32EUCTR2008-006953-41-NL
(EUCTR)
05/08/200926/02/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
33NCT00838513
(ClinicalTrials.gov)
July 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
34NCT00844428
(ClinicalTrials.gov)
July 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
35EUCTR2008-006954-17-DE
(EUCTR)
18/06/200919/02/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
36EUCTR2008-006954-17-ES
(EUCTR)
10/06/200908/04/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
37EUCTR2008-006955-28-AT
(EUCTR)
10/06/200918/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
38EUCTR2008-006952-23-AT
(EUCTR)
10/06/200918/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
39EUCTR2008-006954-17-AT
(EUCTR)
10/06/200918/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
40EUCTR2008-006952-23-ES
(EUCTR)
10/06/200907/04/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
41EUCTR2008-006953-41-AT
(EUCTR)
10/06/200918/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
42EUCTR2008-006955-28-ES
(EUCTR)
10/06/200908/04/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
43EUCTR2008-006953-41-IT
(EUCTR)
04/06/200911/12/2009AN 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: 12.1;Level: LLT;Classification code 10018933;Term: Haemolytic-uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: Eculizumab
ALEXION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
7Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
44EUCTR2008-006952-23-IT
(EUCTR)
04/06/200911/12/2009AN 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: 12.1;Level: LLT;Classification code 10018933;Term: 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
45EUCTR2008-006955-28-IT
(EUCTR)
04/06/200911/12/2009AN 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: 12.1;Level: LLT;Classification code 10018933;Term: 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
46EUCTR2008-006954-17-IT
(EUCTR)
04/06/200911/12/2009AN 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: 12.1;Level: LLT;Classification code 10018933;Term: 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
47EUCTR2008-006954-17-GB
(EUCTR)
28/05/200915/04/2009AN 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
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
48EUCTR2008-006953-41-GB
(EUCTR)
28/05/200914/04/2009AN 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
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
7 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noAustria;Netherlands;Germany;Italy;United Kingdom;Sweden
49EUCTR2008-006955-28-GB
(EUCTR)
28/05/200914/04/2009AN 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
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
50EUCTR2008-006952-23-GB
(EUCTR)
28/05/200915/04/2009AN 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
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
8 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
51NCT00844844
(ClinicalTrials.gov)
May 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
52NCT00844545
(ClinicalTrials.gov)
May 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
53EUCTR2008-006955-28-SE
(EUCTR)
15/04/200904/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
54EUCTR2008-006954-17-SE
(EUCTR)
15/04/200904/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
55EUCTR2008-006953-41-SE
(EUCTR)
15/04/200904/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
56EUCTR2008-006952-23-SE
(EUCTR)
15/04/200904/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
57EUCTR2008-006952-23-FR
(EUCTR)
09/04/200919/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
8Phase 2United Kingdom;Sweden;Italy;France;Spain;Austria;Netherlands;Germany
58EUCTR2008-006954-17-FR
(EUCTR)
09/04/200919/03/2009AN 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: 9.1;Level: LLT;Classification code 10018932;Term: 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
15Sweden;Austria;Italy;Spain;France;Netherlands;Germany;United Kingdom
59EUCTR2010-020310-28-FR
(EUCTR)
05/11/2010AN 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: 12.1;Level: LLT;Classification code 10019515;Term: 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
60EUCTR2015-003135-35-IT
(EUCTR)
20/04/2018EVIDENCE - 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: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System 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