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"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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 PharmaceuticalsNot yet recruiting12 YearsN/AAll12Phase 2Italy
2EUCTR2019-001619-21-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
HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
10Phase 4Spain
3EUCTR2016-002499-29-FR
(EUCTR)
07/06/201915/03/2018Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
16Phase 3United States;France;Belgium;Spain;Austria;Germany;Italy;United Kingdom;Sweden
4EUCTR2016-004129-18-LT
(EUCTR)
15/03/201929/01/2019An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: rVA576
INN or Proposed INN: rVA576
Other descriptive name: COVERSIN
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom;India
5NCT03518203
(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, CincinnatiNULLRecruitingN/AN/AAll21Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-003916-37-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]Newcastle Upon Tyne Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
50Phase 2United Kingdom
7EUCTR2017-002057-11-PL
(EUCTR)
15/02/201811/08/2017A study to investigate the safety and efficacy of study drug OMS721 in adults and adolescents with Atypical Hemolytic Uremic Syndrome.A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents. 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]
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80Phase 3United States;Taiwan;Poland;Lithuania
8EUCTR2016-004129-18-NL
(EUCTR)
14/02/201816/11/2017An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: Coversin Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Coversin
Product Code: rVA576
INN or Proposed INN: COVERSIN
Other descriptive name: COVERSIN
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3Argentina;Poland;Lithuania;Netherlands;United Kingdom
9EUCTR2017-001082-24-SE
(EUCTR)
20/11/201727/09/2017An international study at different study sites providing a drug called cemdisiran (ALN-CC5) to patients with Atypical Hemolytic Uremic Syndrome by a subcutaneous injectionA Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients with Atypical Hemolytic Uremic Syndrome 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]
Alnylam Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
24Phase 2Serbia;Estonia;Lithuania;India;Canada;Macedonia, the former Yugoslav Republic of;Romania;Albania;Georgia;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina
10NCT03303313
(ClinicalTrials.gov)
September 19, 201725/9/2017A Study of an Investigational Drug, Cemdisiran (ALN-CC5), in Patients With Atypical Hemolytic Uremic SyndromeA Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients With Atypical Hemolytic Uremic SyndromeAtypical Hemolytic Uremic SyndromeDrug: CemdisiranAlnylam PharmaceuticalsNULLWithdrawn18 YearsN/AAll0Phase 2Bosnia and Herzegovina;Canada;Estonia;Georgia;Latvia;Lithuania;Macedonia, The Former Yugoslav Republic of;Moldova, Republic of;Serbia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-002057-11-LT
(EUCTR)
15/09/201710/08/2017A study to investigate the safety and efficacy of study drug OMS721 in adults and adolescents with Atypical Hemolytic Uremic Syndrome.A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents. 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]
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80Phase 3United States;Taiwan;Poland;Lithuania
12EUCTR2017-001082-24-EE
(EUCTR)
15/09/201716/08/2017An international study at different study sites providing a drug called cemdisiran (ALN-CC5) to patients with Atypical Hemolytic Uremic Syndrome by a subcutaneous injectionA Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients with Atypical Hemolytic Uremic Syndrome 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]
Alnylam Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
24Phase 2Serbia;Estonia;Lithuania;India;Canada;Macedonia, the former Yugoslav Republic of;Romania;Albania;Georgia;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina
13EUCTR2017-000064-15-GB
(EUCTR)
14/09/201728/06/2017A study of Safety and Efficacy of Coversin in adult aHUS subjects A Phase 2, single arm study of Safety and Efficacy of Coversin in adult aHUS subjects Atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 20.0;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Akari Therapeutics Plc,NULLNot Recruiting Female: yes
Male: yes
10Phase 2United Kingdom
14NCT03131219
(ClinicalTrials.gov)
August 31, 201724/4/2017Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic Syndrome (aHUS)Biological: RavulizumabAlexion PharmaceuticalsNULLActive, not recruitingN/A17 YearsAll31Phase 3United States;Belgium;Germany;Italy;Japan;Korea, Republic of;Spain;United Kingdom
15EUCTR2017-001082-24-LT
(EUCTR)
23/08/201727/06/2017An international study at different study sites providing a drug called cemdisiran (ALN-CC5) to patients with Atypical Hemolytic Uremic Syndrome by a subcutaneous injectionA Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients with Atypical Hemolytic Uremic Syndrome 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-CC5
INN or Proposed INN: cemdisiran
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2Serbia;Estonia;Lithuania;India;Canada;Macedonia, the former Yugoslav Republic of;Romania;Albania;Georgia;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2016-002499-29-BE
(EUCTR)
18/08/201711/05/2017Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Ravulizumab
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 3United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden
17EUCTR2017-001082-24-LV
(EUCTR)
18/08/201720/06/2017An international study at different study sites providing a drug called cemdisiran (ALN-CC5) to patients with Atypical Hemolytic Uremic Syndrome by a subcutaneous injectionA Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients with Atypical Hemolytic Uremic Syndrome 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]
Alnylam Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
24Phase 2Serbia;Estonia;Macedonia, the former Yugoslav Republic of;Canada;Romania;Lithuania;Georgia;Albania;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina
18EUCTR2016-002499-29-IT
(EUCTR)
16/08/201730/01/2018Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
16Phase 3France;United States;Belgium;Spain;Austria;Germany;United Kingdom;Italy;Sweden
19EUCTR2016-002027-29-BE
(EUCTR)
22/06/201728/02/2017Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55Phase 3France;United States;Czech Republic;Spain;Belgium;Austria;Australia;Germany;Japan;United Kingdom;Sweden;Korea, Republic of
20EUCTR2016-002499-29-SE
(EUCTR)
21/06/201721/03/2017Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Ravulizumab
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
23Phase 3United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2016-002499-29-ES
(EUCTR)
31/05/201731/03/2017Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 3United States;Spain
22EUCTR2016-002499-29-DE
(EUCTR)
24/05/201715/02/2017Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Ravulizumab
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 3United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden
23EUCTR2016-002499-29-GB
(EUCTR)
18/05/201709/02/2017Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Ravulizumab
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 3United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden
24EUCTR2016-002499-29-AT
(EUCTR)
28/04/201708/03/2017Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Ravulizumab
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
23Phase 3United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden
25EUCTR2016-002027-29-SE
(EUCTR)
19/04/201716/02/2017Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000012947;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
55Phase 3United States;France;Czech Republic;Belgium;Spain;Austria;Australia;Germany;United Kingdom;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02949128
(ClinicalTrials.gov)
March 18, 201725/10/2016Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-naïve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic Syndrome (aHUS)Biological: RavulizumabAlexion PharmaceuticalsNULLActive, not recruiting12 YearsN/AAll58Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Russian Federation;Spain;Taiwan;United Kingdom
27EUCTR2016-004129-18-GB
(EUCTR)
17/03/201721/12/2016An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: rVA576
INN or Proposed INN: rVA576
Other descriptive name: rVA576
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom
28NCT03829449
(ClinicalTrials.gov)
March 13, 201720/12/2018rVA576 (Coversin) Long Term Safety and Efficacy Surveillance StudyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance StudyParoxysmal Nocturnal Hemoglobinuria;Atypical Hemolytic Uremic SyndromeDrug: rVA576 (Coversin)AKARI TherapeuticsNULLRecruiting18 YearsN/AAll50Phase 3Poland
29EUCTR2016-004129-18-PL
(EUCTR)
07/03/201718/01/2017An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: rVA576 (Coversin)
Product Code: rVA576
INN or Proposed INN: rVA576 (COVERSIN)
Other descriptive name: rVA576 (COVERSIN)
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom
30NCT03205995
(ClinicalTrials.gov)
February 23, 201717/4/2017Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic SyndromeA Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and AdolescentsThrombotic Microangiopathies;Atypical Hemolytic Uremic SyndromeBiological: OMS721Omeros CorporationNULLUnknown status12 YearsN/AAll80Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2016-002027-29-DE
(EUCTR)
06/02/201721/10/2016Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
55Phase 3United States;France;Czech Republic;Belgium;Spain;Austria;Australia;Germany;United Kingdom;Japan;Sweden;Korea, Republic of
32EUCTR2016-002027-29-ES
(EUCTR)
18/01/201717/11/2016Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 19.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ALXN1210
INN or Proposed INN: ALXN1210
Other descriptive name: ALXN1210
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Austria
33EUCTR2016-002027-29-AT
(EUCTR)
15/12/201611/11/2016Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;France;Czech Republic;Belgium;Spain;Australia;Austria;Germany;United Kingdom;Japan;Sweden;Korea, Republic of
34EUCTR2016-002027-29-GB
(EUCTR)
24/11/201607/10/2016Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55Phase 3France;United States;Czech Republic;Belgium;Spain;Austria;Australia;Germany;Japan;United Kingdom;Sweden;Korea, Republic of
35EUCTR2015-003135-35-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT02614898
(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
37NCT02574403
(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
38NCT02464891
(ClinicalTrials.gov)
June 4, 201526/5/2015Complement Inhibition in aHUS Dialysis PatientsAn Open-label Phase 2 Study to Assess the Effect of C5aR Antagonist Therapy by CCX168 Oral Administration on ex Vivo Thrombus Formation and Disease Activity in ESRD Patients With Atypical Hemolytic Uremic SyndromeAtypical Hemolytic Uremic SyndromeDrug: CCX168Mario Negri Institute for Pharmacological ResearchChemoCentryxTerminated18 YearsN/AAll6Phase 2Italy
39EUCTR2014-004261-24-IT
(EUCTR)
08/05/201525/09/2018PROPOSAL OF STUDY TO DETERMINE IF THE ORAL ADMINISTRATION OF CCX168 INHIBITS THE ACTIVITY 'COMPLEMENT AND THE FORMATION OF CLOTS IN PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME IN DIALYSISAN OPEN-LABEL PHASE 2 STUDY TO ASSESS THE EFFECT OF C5AR ANTAGONIST THERAPY BY CCX168 ORAL ADMINISTRATION ON EX VIVO THROMBUS FORMATION AND DISEASE ACTIVITY IN ESRD PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (ACCESS Study) - Complement inhibition in aHUS dialysis patients 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: CCX168
Product Code: CCX168
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLNot RecruitingFemale: yes
Male: yes
10Phase 2Italy
40EUCTR2014-001032-11-PL
(EUCTR)
22/10/201421/08/2014A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with thrombotic microangiopathies.A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 20.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
89Phase 2United States;Taiwan;Hong Kong;Thailand;Malaysia;Belgium;Poland;Singapore;Lithuania;Bulgaria;New Zealand;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2014-001032-11-BE
(EUCTR)
10/10/201425/06/2014A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with thrombotic microangiopathies.A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 18.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
89Phase 2United States;Belarus;Hong Kong;Taiwan;Thailand;Turkey;Lithuania;United Kingdom;Italy;Switzerland;Belgium;Malaysia;Poland;Bulgaria;Germany;New Zealand
42EUCTR2014-001032-11-LT
(EUCTR)
30/09/201402/06/2014A study to investigate the safety, pharmacokinetics, pharmacodynamics,immunogenicity, and clinical activity of study drug OMS721 in adults with thromboticmicroangiopathies.A Phase 2, uncontrolled, three-stage, dose-escalation cohort study toevaluate the safety, pharmacokinetics, pharmacodynamics,immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS)- hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 20.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
89Phase 2United States;Taiwan;Hong Kong;Thailand;Poland;Malaysia;Belgium;Singapore;Lithuania;Bulgaria;New Zealand;Italy
43EUCTR2010-020326-18-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom
44NCT01757431
(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
45EUCTR2010-020310-28-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2010-020310-28-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15United Kingdom;Canada;Netherlands;Belgium;Spain;Italy;United States;Austria;Australia
47EUCTR2010-020310-28-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
48EUCTR2010-020326-18-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
49EUCTR2010-020310-28-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
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
20Phase 2France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
50EUCTR2010-020326-18-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2010-020310-28-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
52EUCTR2010-020326-18-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
53EUCTR2010-020310-28-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
54EUCTR2010-020326-18-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Germany;United Kingdom;Netherlands;Belgium;Spain;Italy
55EUCTR2010-020310-28-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2010-020326-18-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
57EUCTR2010-020326-18-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
58NCT01193348
(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
59NCT01194973
(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
60EUCTR2008-006953-41-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2008-006952-23-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
62EUCTR2008-006955-28-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
63EUCTR2008-006954-17-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
64EUCTR2008-006955-28-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
65EUCTR2008-006952-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2008-006953-41-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
67NCT00838513
(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
68NCT00844428
(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
69EUCTR2008-006954-17-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
70EUCTR2008-006954-17-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2008-006952-23-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
72EUCTR2008-006952-23-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
73EUCTR2008-006953-41-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
74EUCTR2008-006955-28-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
75EUCTR2008-006954-17-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2008-006955-28-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
77EUCTR2008-006953-41-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
78EUCTR2008-006952-23-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
79EUCTR2008-006955-28-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
80EUCTR2008-006954-17-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2008-006955-28-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
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
15Phase 2Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
82EUCTR2008-006954-17-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
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
15Phase 2France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
83EUCTR2008-006953-41-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
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
7Phase 2Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
84EUCTR2008-006952-23-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
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
8Phase 2France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
85NCT00844844
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT00844545
(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
87EUCTR2008-006955-28-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
88EUCTR2008-006954-17-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
89EUCTR2008-006953-41-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
90EUCTR2008-006952-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2008-006952-23-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
8United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden
92EUCTR2008-006954-17-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
15United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden
93EUCTR2010-020310-28-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
94EUCTR2015-003135-35-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
95EUCTR2016-002027-29-CZ
(EUCTR)
22/03/2017Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) 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]
Alexion Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
55Phase 3France;United States;Czech Republic;Belgium;Spain;Austria;Australia;Germany;Japan;United Kingdom;Sweden;Korea, Republic of