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NCT04432584 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
- 20
- Study locations
NCT04432584: Active Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Hoffmann-La Roche.
NCT04432584 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 190 participants, below the 251-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04432584, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5 (CTCAE v5).
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 |
What the registry record for NCT04432584 still lists
NCT04432584 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 251-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (24% lower).
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.
NCT04432584 names 20 study sites across 7 states, led by Other, São Paulo, Rio Grande do Sul.
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.
What interventions are being tested in trial NCT04432584?
The interventions under investigation include: Eculizumab (DRUG), Crovalimab (DRUG).
Who is sponsoring clinical trial NCT04432584?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Paroxysmal Nocturnal Hemoglobinuria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04432584's enrollment target sits among peer trials
190 4th of 14 higher than 10 of 14 other Paroxysmal Nocturnal Hemoglobinuria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Nocturnal Hemoglobinuria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment
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Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
COMPLETED · Phase 3
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