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A clinical trial to look at how well crovalimab works in adults and adolescents with atypical hemolytic uremic syndrome (aHUS)
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Blood Disorder Atypical Hemolytic Uremic Syndrome (aHUS)
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Trial Identifier
NCT04861259, BO42353, 2020-002475-35,2023-505089-27-00
Condition
Atypical Hemolytic Uremic Syndrome
Official Title
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)
Study Summary
This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.
Eligibility Criteria
All
≥12 Years
No
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.
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com