SOLIRIS® (eculizumab) injection, for intravenous use ( DrugBank: Eculizumab )


1 disease
IDDisease name (Link within this page)Number of trials
62Paroxysmal nocturnal hemoglobinuria1

62. Paroxysmal nocturnal hemoglobinuria


Clinical trials : 271 Drugs : 163 - (DrugBank : 49) / Drug target genes : 22 - Drug target pathways : 106
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000597-26-PT
(EUCTR)
18/05/202123/12/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Crovalimab
Product Code: RO7112689
INN or Proposed INN: CROVALIMAB
Trade Name: SOLIRIS® (eculizumab) injection, for intravenous use
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden