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NCT04861259 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Atypical Hemolytic-Uremic Syndrome, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 3
Development phase
83
Enrollment target
20
Study locations

NCT04861259: Active Phase 3 study of Atypical Hemolytic-Uremic Syndrome, sponsored by Hoffmann-La Roche.

NCT04861259 is a Phase 3 study of Atypical Hemolytic-Uremic Syndrome that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 83 participants, below the 1,025-participant average among 3 other Atypical Hemolytic-Uremic Syndrome trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04861259, a Phase 3 study of Atypical Hemolytic-Uremic Syndrome, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
83 participants
Enrollment target
20
Study locations

Study Summary

This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.

Interventions

  • DRUG Crovalimab

Study Locations (20)

Other

  • UZ Leuven Gasthuisberg - Leuven
  • Peking University First Hospital - Beijing
  • Hopital Lapeyronie - Montpellier
  • Hôpital Arnaud de Villeneuve - Montpellier
  • Hôpital Robert Debré - Paris
  • Hopital Tenon - Paris
  • Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin - Cologne
  • Universitätsklinikum Essen - Essen
  • Klinik für Nephrologie des Universitätsklinikum Essen - Essen

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • The Ohio State University Wexner Medical Center - Columbus

São Paulo

  • UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu - Botucatu
  • Hospital das Clinicas - FMUSP - São Paulo

California

  • Univ of CA San Francisco - San Francisco

Colorado

  • Children's Hospital Colorado - Aurora

Georgia

  • Emory Children's Center - Atlanta

Missouri

  • Washington University - St Louis

Texas

  • UT Health Science Center - San Antonio

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2021-10-22
Est. Completion 2029-08-20
Phase Phase 3
Hoffmann-La Roche

909 total trials

What the registry record for NCT04861259 still lists

NCT04861259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 1,025-participant average among 3 other Atypical Hemolytic-Uremic Syndrome trials with a reported enrollment target (92% lower).

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.

NCT04861259 names 20 study sites across 10 states, led by Other, Ohio, São Paulo.

Frequently Asked Questions

What is clinical trial NCT04861259 about?

NCT04861259 is a clinical study titled "A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)". This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.

What is the current status of trial NCT04861259?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2021-10-22. Estimated completion is 2029-08-20.

What conditions does trial NCT04861259 study?

This clinical trial studies the following conditions: Atypical Hemolytic-Uremic Syndrome.

What interventions are being tested in trial NCT04861259?

The interventions under investigation include: Crovalimab (DRUG).

Who is sponsoring clinical trial NCT04861259?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04861259 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04861259, the US trial registry maintained by the National Library of Medicine. NCT04861259 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.