109. 非典型溶血性尿毒症症候群 Atypical hemolytic uremic syndrome Clinical trials / Disease details


臨床試験数 : 115 薬物数 : 37 - (DrugBank : 7) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 10

  
No.TrialIDDate_
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PhaseCountries
1EUCTR2020-002437-15-HU
(EUCTR)
18/01/202206/12/2021A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japan
2NCT04889430
(ClinicalTrials.gov)
January 17, 20227/5/2021Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor TherapyA Multicenter, Single-arm, Open Label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult aHUS Patients Who Are Naive to Complement Inhibitor TherapyAtypical Hemolytic Uremic SyndromeDrug: IptacopanNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll50Phase 3Austria;Greece;Japan;Korea, Republic of;Slovenia;Taiwan
3JPRN-jRCT2041210086
24/12/202118/10/2021A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic SyndromeRO7112689 (crovalimab): Intravenous and SubcutaneousMona D. ShahNULLRecruitingNot applicable<= 17age oldBoth35Phase 3Belgium;Brazil;Canada;France;Hungary;Israel;Italy;China;Poland;South Africa;Spain;United States;Japan
4EUCTR2020-002437-15-IT
(EUCTR)
21/12/202126/01/2022A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) - na Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Crovalimab
Product Code: [RO7112689/F03-10]
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Name: Crovalimab
Product Code: [RO7112689/F03-01]
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japan
5EUCTR2020-002437-15-PL
(EUCTR)
08/12/202104/10/2021A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Poland;Brazil;Belgium;South Africa;China;Japan
6NCT04958265
(ClinicalTrials.gov)
November 16, 20216/7/2021A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Pediatric Patients With Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic SyndromeDrug: CrovalimabHoffmann-La RocheChugai PharmaceuticalRecruitingN/A17 YearsAll35Phase 3United States;Canada;China;France;Italy;Japan;Poland;Belgium;Brazil;Hungary;Israel;South Africa;Spain
7EUCTR2020-005186-13-SI
(EUCTR)
05/11/202114/09/2021Efficacy and safety of iptacopan (LNP023) in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor therapyA multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy atypical hemolytic uremic syndrome
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3United States;Czechia;Taiwan;Slovenia;Greece;Austria;Russian Federation;United Kingdom;India;Hungary;Brazil;China;Japan;Korea, Republic of
8EUCTR2020-002437-15-FR
(EUCTR)
28/10/202102/09/2021A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Brazil;Belgium;Poland;South Africa;China;Japan
9NCT04861259
(ClinicalTrials.gov)
October 22, 202123/4/2021A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic SyndromeDrug: CrovalimabHoffmann-La RocheChugai PharmaceuticalRecruiting12 YearsN/AAll90Phase 3United States;Belgium;Brazil;Canada;China;France;Germany;Hungary;Israel;Italy;Japan;Mexico;Poland;South Africa;Spain;Turkey;Peru
10EUCTR2020-002437-15-ES
(EUCTR)
23/09/202123/07/2021A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, OPEN-LABEL, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB IN ADOLESCENT AND PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Roche Farma S. A. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Brazil;Belgium;Poland;South Africa;China;Japan
11EUCTR2020-005186-13-AT
(EUCTR)
26/08/202127/05/2021Efficacy and safety of iptacopan (LNP023) in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor therapyA multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy atypical hemolytic uremic syndrome
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3United States;Czechia;Taiwan;Greece;Austria;Russian Federation;United Kingdom;India;Hungary;Brazil;China;Japan;Korea, Republic of
12EUCTR2020-002475-35-FR
(EUCTR)
06/08/202122/06/2021A Study Evaluating the Efficacy and Safety of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: crovalimab
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Czechia;Spain;Turkey;Luxembourg;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;Peru;South Africa;Germany;China;Korea, Republic of
13EUCTR2020-002475-35-IT
(EUCTR)
15/06/202107/06/2021A Study Evaluating the Efficacy and Safety of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) - COMMUTE-a Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: crovalimab
Product Code: [RO7112689/F03-10]
INN or Proposed INN: crovalimab
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Czechia;Spain;Turkey;Luxembourg;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;Peru;South Africa;Germany;China;Korea, Republic of
14EUCTR2020-002475-35-DE
(EUCTR)
08/06/202119/03/2021A Study Evaluating the Efficacy and Safety of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: crovalimab
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Czechia;Spain;Turkey;Luxembourg;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;Peru;South Africa;Germany;China;Korea, Republic of
15JPRN-jRCT2031210061
20/05/202127/04/2021A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants with Atypical Hemolytic Uremic Syndrome (aHUS)A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) Atypical Hemolytic Uremic SyndromeRO7112689 (crovalimab): Intravenous and SubcutaneousCamelia SimaNULLRecruiting>= 12age oldNot applicableBoth90Phase 3CANADA;BELGIUM;FRANCE;UNITED STATES;BRAZIL;POLAND;MEXICO;GERMANY;CHINA;Japan
16EUCTR2020-002475-35-PL
(EUCTR)
20/05/202121/04/2021A Study Evaluating the Efficacy and Safety of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: crovalimab
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Czechia;Spain;Turkey;Luxembourg;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;Peru;South Africa;Germany;China;Korea, Republic of
17NCT03999840
(ClinicalTrials.gov)
January 202125/6/2019Eculizumab to Cemdisiran Switch in aHUSA Phase II, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Cemdisiran (ALN-CC5) Following Withdrawal of Chronic Eculizumab Therapy in Patients With Atypical HUS at High Risk of RecurrenceAtypical Hemolytic Uremic SyndromeDrug: cemdisiran;Drug: PlacebosMario Negri Institute for Pharmacological ResearchAlnylam PharmaceuticalsWithdrawn12 YearsN/AAll0Phase 2Italy
18NCT04749810
(ClinicalTrials.gov)
December 19, 20198/2/2021Observational Study of Elizaria® in aHUS PatientsProspective Observational Study of Long-term Pathogenic Treatment of Elizaria® in Patients With Atypical Hemolytic Uremic SyndromeAtypical Hemolytic Uremic Syndrome;aHUSDrug: Elizaria®AO GENERIUMNULLRecruiting2 MonthsN/AAll50Russian Federation
19EUCTR2018-004382-13-IT
(EUCTR)
28/11/201925/05/2021Safety and efficacy of Cemdisiran in athypical hemolytic uremic syndromeA PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CEMDISIRAN (ALN-CC5) FOLLOWING WITHDRAWAL OF CHRONIC ECULIZUMAB THERAPY IN PATIENTS WITH ATYPICAL HUS AT HIGH RISK OF RECURRENCE - Eculizumab to Cemdisiran switch in aHUS Atypical Hemolytic Uremic Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ALN-CC5
Product Code: [ALN-62643]
INN or Proposed INN: Cemdisiran
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLNot RecruitingFemale: yes
Male: yes
12Phase 2Italy
20EUCTR2019-001619-21-ES
(EUCTR)
07/10/201911/06/2019OPTIMIZATION OF MAINTENANCE DOSE WITH ECULIZUMAB ACCORDING TO WEIGHT IN PATIENTS WITH ATYPIC HAEMOLITHIC URINE MUSCLE SYNDROMEPILOT STUDY FOR THE OPTIMITZATION OF THE MAINTENANCE DOSE OF ECULIZUMAB ACCORDING TO THE WEIGHT IN ADULT PATIENTS WITH ATYPIC HEMOLYTIC UREMIC SYNDROME - OPTIMAB ATYPICAL HEMOLYTIC UREMIC SYNDROME
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851 ;Therapeutic area: Not possible to specify
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain
21EUCTR2016-002499-29-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]
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 finished Female: yes
Male: yes
16 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Belgium;Spain;Austria;Germany;Italy;United Kingdom;Sweden
22EUCTR2016-004129-18-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
23NCT03518203
(ClinicalTrials.gov)
August 3, 20185/3/2018Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant RecipientsEarly Intervention With Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome (TMA/aHUS)-Associated Multiple Organ Dysfunction Syndrome (MODS) in Hematopoietic Stem Cell Transplant (HCT) RecipientsThrombotic Microangiopathies;Atypical Hemolytic Uremic Syndrome;Multiple Organ Dysfunction SyndromeDrug: EculizumabChildren's Hospital Medical Center, CincinnatiNULLActive, not recruitingN/AN/AAll23Phase 2United States
24EUCTR2017-003916-37-GB
(EUCTR)
13/04/201819/02/2018Stopping Eculizumab Treatment Safely in atypical Haemolytic Uraemic Syndrome (SETS aHUS)Multicentre, open label, prospective, single arm study of the safety and impact of eculizumab withdrawal in patients with atypical haemolytic uraemic syndrome - SETS aHUS: Stopping Eculizumab Treatment Safely in aHUS Atypical Haemolytic Uraemic Syndrome (aHUS);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Solaris
Product Name: Solaris
INN or Proposed INN: Eculizumab
Other descriptive name: IgG2/4?
Newcastle Upon Tyne Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
25EUCTR2017-002057-11-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]
Product Code: OMS721 Drug Product 185 mg/mL
INN or Proposed INN: not yet available
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721 Drug Product 185 mg/mL
INN or Proposed INN: not yet available
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Poland;Lithuania
26EUCTR2016-004129-18-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
27EUCTR2017-001082-24-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]
Product Name: ALN-CC5
Product Code: ALN-CC5
INN or Proposed INN: cemdisiran
Alnylam Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Estonia;Lithuania;India;Canada;Macedonia, the former Yugoslav Republic of;Romania;Albania;Georgia;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina
28NCT03303313
(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
29EUCTR2017-002057-11-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]
Product Code: OMS721 Drug Product 185 mg/mL
INN or Proposed INN: not yet available
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721 Drug Product 185 mg/mL
INN or Proposed INN: not yet available
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Poland;Lithuania
30EUCTR2017-001082-24-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]
Product Name: ALN-CC5
Product Code: ALN-CC5
INN or Proposed INN: cemdisiran
Alnylam Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Estonia;Lithuania;India;Canada;Macedonia, the former Yugoslav Republic of;Romania;Albania;Georgia;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina
31EUCTR2017-000064-15-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]
Product Name: Coversin
Product Code: rVA576
INN or Proposed INN: Coversin
Other descriptive name: COVERSIN
Akari Therapeutics Plc,NULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
32NCT03131219
(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
33EUCTR2017-001082-24-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
34EUCTR2016-002499-29-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;Sweden;Korea, Republic of
35EUCTR2017-001082-24-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]
Product Name: ALN-CC5
Product Code: ALN-CC5
INN or Proposed INN: cemdisiran
Alnylam Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Estonia;Macedonia, the former Yugoslav Republic of;Canada;Romania;Lithuania;Georgia;Albania;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina
36EUCTR2016-002499-29-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
37EUCTR2016-002027-29-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]
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;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden
38EUCTR2016-002499-29-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
39EUCTR2016-002499-29-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
40EUCTR2016-002499-29-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 3Sweden;Korea, Republic of;Japan;Germany;Australia;Belgium;Canada;France;Italy;United Kingdom;Russian Federation;Austria;Spain;Taiwan;United States
41EUCTR2016-002499-29-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
42EUCTR2016-002499-29-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
43EUCTR2016-002027-29-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
44NCT02949128
(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
45EUCTR2016-004129-18-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
46EUCTR2016-004129-18-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
47NCT03205995
(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
48EUCTR2016-002027-29-IT
(EUCTR)
15/02/201702/02/2021Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Na¿ve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Na¿ve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) - Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Na¿ve Adult and Adolescent Patients w 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: ALXN1210
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
55Phase 3United States;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden
49EUCTR2016-002027-29-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
50EUCTR2016-002027-29-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
51EUCTR2016-002027-29-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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
55Phase 3United States;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden
52EUCTR2016-002027-29-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]
Product Code: ALXN1210
INN or Proposed INN: ALXN1210
Other descriptive name: ALXN1210
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Belgium;Spain;Austria;Australia;Germany;Japan;United Kingdom;Sweden;Korea, Republic of
53EUCTR2015-003135-35-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
54NCT02614898
(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
55NCT02574403
(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
56NCT02464891
(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
57EUCTR2014-004261-24-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
58EUCTR2014-001032-11-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
59EUCTR2014-001032-11-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
60EUCTR2014-001032-11-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
61EUCTR2010-020326-18-FR
(EUCTR)
25/03/201321/09/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROMEAN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 12.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom
62NCT01757431
(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
63EUCTR2010-020310-28-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
64EUCTR2010-020310-28-ES
(EUCTR)
07/11/201108/09/2011-AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) - - Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
15Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Germany;Netherlands;Italy;United Kingdom
65EUCTR2010-020310-28-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
66EUCTR2010-020326-18-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
67EUCTR2010-020310-28-GB
(EUCTR)
01/02/201121/10/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
68EUCTR2010-020326-18-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
69EUCTR2010-020310-28-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
70EUCTR2010-020326-18-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
71EUCTR2010-020310-28-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
72EUCTR2010-020326-18-ES
(EUCTR)
12/01/201118/10/2010AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROMEAN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME pacientes adultos con síndrome hemolítico urémico atípico; Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS):
MedDRA version: 12.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome
Trade Name: SOLIRIS 300 mg concentrado para solución para perfusión
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ECULIZUMAB
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
73EUCTR2010-020310-28-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
74EUCTR2010-020326-18-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
75EUCTR2010-020326-18-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
76NCT01193348
(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
77NCT01194973
(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
78EUCTR2008-006953-41-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
79EUCTR2008-006952-23-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
80EUCTR2008-006955-28-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
81EUCTR2008-006954-17-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
82EUCTR2008-006955-28-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
83EUCTR2008-006952-23-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
84EUCTR2008-006953-41-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
85NCT00838513
(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
86NCT00844428
(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
87EUCTR2008-006954-17-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
88EUCTR2008-006954-17-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
89EUCTR2008-006952-23-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
90EUCTR2008-006952-23-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
91EUCTR2008-006953-41-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
92EUCTR2008-006955-28-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
93EUCTR2008-006954-17-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
94EUCTR2008-006955-28-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
95EUCTR2008-006953-41-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
96EUCTR2008-006952-23-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
97EUCTR2008-006955-28-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
98EUCTR2008-006954-17-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
99EUCTR2008-006955-28-GB
(EUCTR)
28/05/200914/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
100EUCTR2008-006954-17-GB
(EUCTR)
28/05/200915/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
101EUCTR2008-006953-41-GB
(EUCTR)
28/05/200914/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS).
MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
7 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noAustria;Netherlands;Germany;Italy;United Kingdom;Sweden
102EUCTR2008-006952-23-GB
(EUCTR)
28/05/200915/04/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot Recruiting Female: yes
Male: yes
8 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
103NCT00844844
(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
104NCT00844545
(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
105EUCTR2008-006955-28-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
106EUCTR2008-006954-17-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
107EUCTR2008-006953-41-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
108EUCTR2008-006952-23-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
109EUCTR2008-006952-23-FR
(EUCTR)
09/04/200919/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS)
MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
8Phase 2United Kingdom;Sweden;Italy;France;Spain;Austria;Netherlands;Germany
110EUCTR2008-006954-17-FR
(EUCTR)
09/04/200919/03/2009AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome
Trade Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Sweden;Austria;Italy;Spain;France;Netherlands;Germany;United Kingdom
111EUCTR2010-020310-28-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
112EUCTR2015-003135-35-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
113EUCTR2020-002437-15-BE
(EUCTR)
03/09/2021A Study Evaluating the Efficacy and Safety of Crovalimab in Pediatric Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB IN ADOLESCENT AND PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F.Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
35Phase 3United States;Spain;Israel;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;South Africa;China;Japan
114EUCTR2016-002027-29-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]
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 Recruiting Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Belgium;Spain;Austria;Australia;Germany;Japan;United Kingdom;Sweden;Korea, Republic of
115EUCTR2020-002475-35-BE
(EUCTR)
19/03/2021A Study Evaluating the Efficacy and Safety of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) Atypical Hemolytic Uremic Syndrome (aHUS)
MedDRA version: 20.1;Level: LLT;Classification code 10079841;Term: Atypical hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: crovalimab
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
90Phase 3United States;Czechia;Spain;Turkey;Luxembourg;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;Peru;South Africa;Germany;China;Korea, Republic of