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)

🧪 Interventions in This Study

• Crovalimab (DRUG)
• Eculizumab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Body weight ≥ 40 kg at screening (pediatric participants with body weight \< 40 kg)
2. Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1
3. Lactate Dehydrogenase Levels ≤ 2x the upper limit of normal (ULN) at screening
4. Willingness and ability to comply with all study visits and procedures
5. Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry
6. Vaccination against Neisseria meningitidis serotypes A, C, W, and Y \< 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration
7. Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (80 Sites)

Showing the first 25 of 80 sites.

• Carolinas Healthcare System — Charlotte, North Carolina
• Nationwide Children's Hospital — Columbus, Ohio
• Cliniques Universitaires Saint-Luc — Brussels,
• AZ Delta Campus Westlaan — Roeselare,
• Chronos Pesquisa Clinica — Taguatinga, Federal District
• Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul
• Hospital de Clínicas de Porto Alegre X — Porto Alegre, Rio Grande do Sul
• Instituto Joinvilense de Hematologia E Oncologia — Joinville, Santa Catarina
• Hospital das Clínicas FMRP-USP — Ribeirão Preto, São Paulo
• *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia — Santo André, São Paulo
• Hospital Sírio-Libanês — São Paulo, São Paulo
• Hospital Paulistano — São Paulo, São Paulo
• 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,
• Institut Paoli Calmette — Marseille,
• Universitaetsklinikum Aachen AOeR — Aachen,
• ELBLANDKLINIKUM Riesa — Riesa,
• General Hospital of Athens LAIKO — Athens,
• Attikon University General Hospital — Athens,
• Prince of Wales Hospital — Hong Kong,
• Semmelweis Egyetem — Budapest,
• St James's Hospital — Dublin,
• Azienda Unita Sanitaria Locale- Ravenna — Ravenna, Emilia-Romagna

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Paroxysmal Nocturnal Hemoglobinuria

• Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis of IPIG-Registry Data — Boston, Massachusetts
• A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors — Ciudad Autonoma Buenos Aires,
• Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis — Saskatoon, Saskatchewan
• The International PNH Interest Group PNH Registry — Altamonte Springs, Florida
• A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Whose Current Treatment is Not Working Efficiently — Ribeirão Preto, São Paulo
• Long-term Safety of Danicopan: IPIG Registry-based Cohort Study — Boston, Massachusetts

Explore by condition: All Paroxysmal Nocturnal Hemoglobinuria clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.