Clinical Trial

REAL-CARE: Real-world Effectiveness of Iptacopan in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria

Study acronym: REAL-CARE
Recruiting
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Summary
This study evaluates iptacopan effectiveness and safety in routine clinical practice, with a focus on hematological response, transfusion avoidance, and patient-reported outcomes. The primary objective of the REAL-CARE study is to is to assess the long-term hematological response following iptacopan initiation. This will be assessed through the absolute change in hemoglobin (Hb) levels at 12 months post-initiation, and the proportion of patients who remain free from red blood cell (RBC) transfusions, prescribed as per local requirement and based on Investigator's judgment, from Day 14 through Month 12 after starting iptacopan.
Protocol Amendment History 3 changes
notable Trial sites expanded: 7 -> 10 locations 2026-05-19
critical Recruitment opened 2026-04-17
notable Trial sites expanded: 0 -> 7 locations 2026-04-17
Trial Details
NCT Number NCT07229235
Lead Sponsor Novartis Pharmaceuticals
Conditions Paroxysmal Nocturnal Hemoglobinuria (PNH)
Enrollment 50 participants
Start Date 2026-01-13
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-25