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A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors
EU CTIS ID: 2023-506498-36-00
What this study is testing
To evaluate the efficacy of crovalimab compared to eculizumab based on the non-inferiority assessment of the following co-primary endpoints
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Body weight ≥ 40 kg (pediatric patients with body weight < 40 kg)
- Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry evaluation of WBCs
- LDH level ≥2 x ULN at screening (as per local assessment)
- Platelet count >= 30,000/mm*3 at screening without transfusion support within 7 days of lab testing
- ANC > 500/micro L at screening
- For female patients of childbearing potential: agreement to remain abstinent or use contraception
You likely can't join if
- 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
- Splenectomy <= 6 months prior to screening
- History of or ongoing cryoglobulinemia at screening
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Ukraine
- Mexico
- Philippines
- Saudi Arabia
- Singapore
- Turkey
- China
- Colombia
- United Kingdom
- Australia
- Argentina
- Japan
- Peru
- Thailand
- Brazil
- Israel
- Korea, Republic of
- Hong Kong
- South Africa
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Ukraine; Mexico; Philippines; Saudi Arabia; Singapore and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.