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A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
NCT04432584 · View on ClinicalTrials.gov ↗
Study Summary
A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.
Conditions Studied
Interventions
- DRUG Eculizumab
- DRUG Crovalimab
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc — Brussels
- AZ Delta Campus Westlaan — Roeselare
- CHU UCL Namur / site Godinne — Yvoir
- Beneficencia Portuguesa de Sao Paulo — São Paulo
- Ustav hematologie a krevni transfuze — Prague
- North Estonia Medical Centre Foundation — Tallinn
- Hopital Claude Huriez - CHU Lille — Lille
- Universitaetsklinikum Aachen AOeR — Aachen
- ELBLANDKLINIKUM Riesa — Riesa
- General Hospital of Athens LAIKO — Athens
São Paulo
- Hospital das Clínicas FMRP-USP — Ribeirão Preto
- *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia — Santo André
- Hospital Sírio-Libanês — São Paulo
- Hospital Paulistano — São Paulo
Rio Grande do Sul
- Santa Casa de Misericordia de Porto Alegre — Porto Alegre
- Hospital de Clínicas de Porto Alegre X — Porto Alegre
North Carolina
- Carolinas Healthcare System — Charlotte
Ohio
- Nationwide Children's Hospital — Columbus
Federal District
- Chronos Pesquisa Clinica — Taguatinga
Santa Catarina
- Instituto Joinvilense de Hematologia E Oncologia — Joinville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04432584
The ClinicalTrials.gov registry entry for NCT04432584 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 190 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 Paroxysmal Nocturnal Hemoglobinuria appearing as the primary indexed condition, and to 2 interventions — of which Eculizumab 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: NCT04432584 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, São Paulo, Rio Grande do Sul. 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 NCT04432584 about?
NCT04432584 is a clinical study titled "A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors". A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.
What is the current status of trial NCT04432584?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2020-09-30. Estimated completion is 2027-09-30.
What conditions does trial NCT04432584 study?
This clinical trial studies the following conditions: Paroxysmal Nocturnal Hemoglobinuria. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04432584?
The interventions under investigation include: Eculizumab (DRUG), Crovalimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04432584?
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 NCT04432584 being conducted?
This trial has 20 study locations across North Carolina, Ohio, Federal District, Rio Grande do Sul, Santa Catarina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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