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Active (not recruiting) Phase 3 NCT04861259

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Phase 3 – large-scale trial before approval
Conditions: Atypical Hemolytic Uremic Syndrome

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.
Who can participate
Inclusion Criteria: * Body weight \>= 40 kg at screening. * Vaccination against Neisseria meningitidis serotypes A, C, W, and Y; vaccination against serotypes B, according to national vaccination recommendations. * Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae, according to national vaccination recommendations. * For participants continuing to receive other therapies concomitantly with crovalimab (e.g., immunosuppressants, corticosteroids, mammalian target of rapamycin inhibitor (mTORi) , or calcineurin inhibitors): stable dose for \>=28 days prior to screening and up to the first crovalimab administration. * For female participants of childbearing potential: an agreement to remain abstinent or use contraception. * Female participants of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of crovalimab. * Participants with a prior kidney transplant are eligible if they have a known history of complement-mediated aHUS prior to the kidney transplant. * Onset of initial TMA presentation within 28 days prior to the first dose of crovalimab (for Naive Cohort only). * Documented treatment with either eculizumab or ravulizumab (for Switch Cohort only). * Clinical evidence of response to a C5 inhibitor (for Switch Cohort only). * Known C5 polymorphism (for C5 SNP Cohort only). * Poorly controlled TMA following treatment with another C5 inhibitor (for C5 SNP Cohort only). Exclusion Criteria: * TMA associated with non-aHUS related renal disease. * Positive direct Coombs test. * Chronic dialysis within 90 days prior to first crovalimab administration and/or end stage renal disease. * Identified drug exposure-related TMA. * Presence or history of a condition that could trigger TMA, such as malignancy, bone marrow or organ transplant (other than kidney transplant) or autoimmune disease. * History of a kidney disease, other than aHUS. * History of Neisseria meningitidis infection within 6 months of study enrollment. * Known or suspected immune deficiency (e.g., history of frequent recurrent infections). * Positive Human Immunodeficiency Virus (HIV) test. * Active systemic bacterial, viral, or fungal infection within 14 days before first crovalimab administration * Presence of fever (\>= 38°C) * Multi-system organ dysfunction or failure. * Recent intravenous immunoglobulin (IVIg) treatment. * Pregnant or breastfeeding or intending to become pregnant. * Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within five half lives of that investigational product, whichever is greater. * Recent use of tranexamic acid. * Current or previous treatment with a complement inhibitor (for Naive Cohort only). * First initiation of plasma exchange/plasma infusions (PE/PI) should not be more than 28 days prior to first crovalimab administration (for Naive Cohort only). * Last PE/PI completed less than 2 hours prior to first crovalimab administration (for Naive Chorot only). * Receiving PE/PI within 8 weeks of the first crovalimab administration (Switch Cohort only). * Positive for active Hepatitis B and C infection (HBV/HCV) (for Switch Cohort and C5 SNP Cohort participants who recently received C5 inhibitor treatment). * Cryoglobulinemia at screening (for Switch Cohort and C5 SNP Cohort participants who recently received C5 inhibitor treatment). * Diagnosis of condition leading to non-aHUS TMA: Thrombotic Thrombocytopenic Purpura (TTP), Shiga Toxin producing Escherichia Coli (STEC) * TMA, Pneumococcal HUS, TMA secondary to cobalamin C defect and TMA related to a known DGKE nephropathy.
Interventions
Crovalimab
DRUG
Locations 42
Belgium (1)
UZ Leuven Gasthuisberg
Leuven
Brazil (3)
Santa Casa de Misericordia
Belo Horizonte , Minas Gerais
UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu
Botucatu , São Paulo
Hospital das Clinicas - FMUSP
São Paulo , São Paulo
Canada (1)
Vancouver General Hospital
Vancouver , British Columbia
China (1)
Peking University First Hospital
Beijing
France (3)
Hopital Lapeyronie
Montpellier
Hôpital Robert Debré
Paris
Hopital Tenon
Paris
Germany (4)
Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
Cologne
Universitätsklinikum Essen
Essen
Klinik für Nephrologie des Universitätsklinikum Essen
Essen
Medizinische Hochschule Hannover
Hanover
Hungary (1)
Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely
Budapest
India (2)
Medanta-The Medicity
Gurgaon , Haryana
All India Institute Of Medical Sciences (AIIMS)
New Delhi , National Capital Territory of Delhi
Israel (3)
Rambam Medical Center
Haifa
Rabin Medical Center
Petah Tikva
Sheba MC
Ramat Gan
Italy (2)
A.O. Universitaria S. Martino Di Genova
Genoa , Liguria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome , Lazio
Japan (3)
Nagoya University Hospital
Aichi
Saitama Medical University Hospital
Saitama
The University of Tokyo Hospital
Tokyo
Mexico (4)
Hospital General de México
Distrito Federal , Mexico CITY (federal District)
Instituto Nacional de Ciencias
Mexico City , Mexico CITY (federal District)
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey , Nuevo León
Hospital de Especialidades Puerta de Hierro S.A de C.V.
Zapopan
Poland (1)
Instytut ?Centrum Zdrowia Matki Polki
Lodz
Spain (3)
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña
Hospital Clinic i Provincial
Barcelona
Hospital Universitario Virgen del Rocío
Seville
Turkey (4)
Istanbul University Istanbul Medical Faculty
Istanbul
Kocaeli University Medical Faculty
Kocaeli
Necmettin Erbakan University Meram Medical Faculty
Konya
Malatya Park Hospital
Malatya
United States (6)
Emory Children's Center
Atlanta , Georgia
Children's Hospital Colorado
Aurora , Colorado
The Ohio State University Wexner Medical Center
Columbus , Ohio
UT Health Science Center
San Antonio , Texas
Univ of CA San Francisco
San Francisco , California
Washington University
St Louis , Missouri
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
22.10.2021
Completion date
20.08.2029
Registry ID
NCT04861259
Source
clinicaltrials.gov
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