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A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
NCT04958265 · View on ClinicalTrials.gov ↗
Study Summary
This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.
Conditions Studied
Interventions
- DRUG Crovalimab
Study Locations (20)
Other
- UZ Gent — Ghent
- UZ Leuven Gasthuisberg — Leuven
- Peking University First Hospital — Beijing
- Beijing Children's Hospital, Capital Medical University — Beijing
- The children's hospital , Zhejiang university school of medicine — Hangzhou
- Hôpital Arnaud de Villeneuve — Montpellier
- Gh Necker Enfants Malades — Paris
- Aichi Children?s Health and Medical Center — Aichi
- Chiba Children's Hospital — Chibashi, Chibaken
- Hospital de Especialidades Puerta de Hierro S.A de C.V. — Zapopan
Colorado
- Children's Hospital Colorado — Aurora
Nebraska
- University of Nebraska — Omaha
New Jersey
- Hackensack University Medical Center — Hackensack
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
Texas
- UT Health Science Center — San Antonio
São Paulo
- Inst. Da Criança- Faculdade de Medicina Usp — São Paulo
Quebec
- CHU Sainte-Justine — Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2029-05-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04958265
The ClinicalTrials.gov registry entry for NCT04958265 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atypical Hemolytic Uremic Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Crovalimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04958265 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Colorado, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04958265 about?
NCT04958265 is a clinical study titled "A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)". This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.
What is the current status of trial NCT04958265?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2021-11-17. Estimated completion is 2029-05-19.
What conditions does trial NCT04958265 study?
This clinical trial studies the following conditions: Atypical Hemolytic Uremic Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04958265?
The interventions under investigation include: Crovalimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04958265?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04958265 being conducted?
This trial has 20 study locations across Colorado, Nebraska, New Jersey, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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