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 109. 非典型溶血性尿毒症症候群 [臨床試験数:23,薬物数:17(DrugBank:3),標的遺伝子数:1,標的パスウェイ数:2] 

Searched query = "Atypical hemolytic uremic syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03999840December 20194 November 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 recruiting12 YearsN/AAll12Phase 2Italy
2NCT03518203August 3, 201828 October 2019Eculizumab 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, CincinnatiRecruitingN/AN/AAll21Phase 2United States
3EUCTR2017-002057-11-PL15/02/201821 May 2018A 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]
Product Code: OMS721 Drug Product 185 mg/mL
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: not yet available
Current Sponsor code: OMS721
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 185-
Product Code: OMS721 Drug Product 185 mg/mL
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: not yet available
Current Sponsor code: OMS721
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 185-
Omeros CorporationAuthorisedFemale: yes
Male: yes
80Phase 3United States;Taiwan;Poland;Lithuania
4NCT03303313September 19, 20179 October 2018A 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 PharmaceuticalsNot recruiting18 YearsN/AAll0Phase 2Bosnia and Herzegovina;Canada;Estonia;Georgia;Latvia;Lithuania;Macedonia, The Former Yugoslav Republic of;Moldova, Republic of;Serbia;Sweden
5EUCTR2017-001082-24-EE15/09/201728 February 2019An 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 SyndromeAtypical 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: cemdisiran
Current Sponsor code: ALN-62643
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Alnylam Pharmaceuticals, Inc.Not 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-000064-15-GB14/09/201725 June 2018A study of Safety and Efficacy of Coversin in adult aHUS subjectsA Phase 2, single arm study of Safety and Efficacy of Coversin in adult aHUS subjectsAtypical 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]
Product Name: Coversin
Product Code: rVA576
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Coversin
Current Sponsor code: rVA576
Other descriptive name: COVERSIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Akari Therapeutics Plc,AuthorisedFemale: yes
Male: yes
10Phase 2United Kingdom
7NCT03131219August 31, 201722 October 2019Study 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)Biological: ALXN1210Alexion PharmaceuticalsRecruitingN/A17 YearsAll28Phase 3United States;Belgium;Germany;Italy;Japan;Korea, Republic of;Spain;United Kingdom
8EUCTR2017-001082-24-LV18/08/201728 February 2019An 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 SyndromeAtypical 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: cemdisiran
Current Sponsor code: ALN-62643
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Alnylam Pharmaceuticals, Inc.Not 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
9EUCTR2016-002499-29-GB18/05/20171 October 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Current Sponsor code: ALXN1210
Other descriptive name: Ravulizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Alexion Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
23Phase 3United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden
10EUCTR2016-004129-18-GB17/03/20175 June 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 StudyParoxysmal nocturnal haemoglobinuria (PNH) and 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
MedDRA version: 20.0 Level: PT 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
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: COVERSIN
Current Sponsor code: rVA576
Other descriptive name: COVERSIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Akari Therapeutics PlcAuthorisedFemale: yes
Male: yes
50Phase 3Argentina;Poland;Netherlands;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03829449March 13, 201711 March 2019rVA576 (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 TherapeuticsRecruiting18 YearsN/AAll50Phase 3Poland
12EUCTR2016-002027-29-GB24/11/201621 August 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ALXN1210
Other descriptive name: ALXN1210
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Alexion Pharmaceuticals IncorporatedAuthorisedFemale: yes
Male: yes
55Phase 3France;United States;Spain;Austria;Australia;Japan;United Kingdom;Korea, Republic of
13NCT02574403November 201516 December 2017Study 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 HospitalNot recruiting3 YearsN/AAll60Phase 4France
14NCT02464891June 4, 201516 December 2017Complement 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 ResearchChemoCentryxNot recruiting18 YearsN/AAll6Phase 2Italy
15EUCTR2014-001032-11-LT30/09/201428 February 2019A 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not yet available
Current Sponsor code: OMS721
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Product Code: OMS721
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not yet available
Current Sponsor code: OMS721
Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 185-
Omeros CorporationAuthorised Female: yes
Male: yes
89Phase 2United States;Hong Kong;Taiwan;Poland;Malaysia;Belgium;Thailand;Singapore;Lithuania;Bulgaria;New Zealand;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01757431May 16, 201216 December 2017The Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic Syndrome (aHUS)Drug: EculizumabAlexion PharmaceuticalsNot recruitingN/AN/AAll2Phase 2Japan
17EUCTR2010-020326-18-GB19/10/201012 May 2014AN 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 SYNDROMEAdult 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: eculizumab
Current Sponsor code: h5G1.1-mAb
Other descriptive name: Anti-C5 antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
ALEXION PHARMACEUTICALS, INC.Not RecruitingFemale: yes
Male: yes
60France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom
18NCT01193348September 201019 October 2017An 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 PharmaceuticalsNot recruiting1 Month18 YearsAll22Phase 2United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;United Kingdom
19NCT01194973July 201016 December 2017An 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 PharmaceuticalsNot recruiting18 YearsN/AAll44Phase 2United States;Belgium;France;Germany;Italy;Spain;United Kingdom
20NCT00838513July 200919 October 2017Open 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 PharmaceuticalsNot recruiting18 YearsN/AAll15Phase 2Canada;France;Germany;Italy;Netherlands;Sweden;United Kingdom;Austria;Spain;Switzerland;United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00844428July 200919 October 2017Open 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 PharmaceuticalsNot recruiting12 Years17 YearsAll5Phase 2Canada;France;Germany;Italy;Netherlands;Sweden;United Kingdom;Austria;Spain;Switzerland;United States
22NCT00844545May 200919 October 2017Open 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 PharmaceuticalsNot recruiting18 YearsN/AAll16Phase 2United States;Austria;France;Germany;United Kingdom;Italy;Netherlands;Spain;Sweden;Switzerland
23NCT00844844May 200919 October 2017Open 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 PharmaceuticalsNot recruiting12 Years17 YearsAll1Phase 2United States;Austria;France;Germany;United Kingdom;Canada;Italy;Netherlands;Spain;Sweden;Switzerland

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