🏛️ Verified NIH Record • Updated 2026-07-27
A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors (NCT04434092)
A Phase III, Randomized, Open-label, Active-controlled, Multicenter Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors
🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche
🩺 Plain-English Summary (8th-Grade Level)
A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (11 items).
Location: Organizacion Medica de Investigacion (OMI) — Ciudad Autonoma Buenos Aires
Age range: 2 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck 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).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Current or previous treatment with a complement inhibitor
- History of allogeneic bone marrow transplantation
- History of Neisseria meningitidis infection within 6 months prior to screening and up to first study drug administration
- History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high
- Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label)
- Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater
- Concurrent disease, treatment, procedure or surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the Investigator, preclude the participant's safe participation in and completion of the study
- Splenectomy \< 6 months before screening
- Positive for Active Hepatitis B and C infection (HBV/HCV)
- History of or ongoing cryoglobulinemia at screening
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (63 Sites)
Showing the first 25 of 63 sites.
- Organizacion Medica de Investigacion (OMI) — Ciudad Autonoma Buenos Aires,
- *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia — Santo André, São Paulo
- Beneficencia Portuguesa de Sao Paulo — São Paulo,
- Peking Union Medical College Hospital — Beijing,
- Nanfang Hospital, Southern Medical University — Guangzhou,
- The First Affiliated Hospital, Zhejiang University — Hangzhou,
- Jiangsu Province Hospital — Nanjing,
- Affiliated Hospital of Nantong University — Nantong,
- Huashan Hospital, Fudan University — Shanghai,
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan,
- Centre Hospitalier Lyon Sud — Pierre-Bnite, Rhone
- Hopital Claude Huriez - CHU Lille — Lille,
- Universitaetsklinkm — Essen,
- Universitaetsklinikum Ulm — Ulm,
- General Hospital of Thessaloniki G. Papanikolaou — Thessaloniki,
- Sapporo Medical University Hospital — Hokkaido,
- University of Tsukuba Hospital — Ibaraki,
- NTT Medical Center Tokyo — Tokyo,
- Tokyo Medical University Hospital — Tokyo,
- Vilnius University Hospital Santariskiu Clinics, Public Institution — Vilnius,
- Hospital Raja Permaisuri Bainun — Ipoh, Perak
- Hospital Pulau Pinang — George Town, Pulau Pinang
- Hospital Ampang — Ampang, Selangor
- Hospital Tengku Ampuan Afzan — Kuantan,
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — Mexico City, Mexico CITY (federal District)
💰 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
- 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
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.