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

Recruitingn/aAges 18 Years - anyAllNovartis Pharmaceuticals
NCT07229235 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion criteria: 1. signed informed consent: patient must provide written informed before any study assessment is collected; in case of deceased patients, informed consent is not required as per Art. 110, comma 1 of Legislative Decree n° 196, dated 30 June 2003 as amended by D.lgs. 101/2018 and the "Autorizzazione generale al trattamento dei dati personali effettuato per scopi di ricerca scientifica" n° 9/2016 2. Male and female, 3. ≥ 18 years of age, 4. documented diagnosis of PNH, 5. followed in Italian clinical sites, 6. on treatment with iptacopan prescribed as per routine medical care (i.e. patients naïve to treatment for whom the decision to start this treatment has already been made on the basis of clinical practice and according to SmPC and AIFA criteria and regardless of inclusion in this study or patients already treated under the Managed Access Program (MAP)) Exclusion criteria: 1.Concomitant participation in an interventional clinical study related to PNH or its treatment. No other inclusion/exclusion criteria apply other than the requirements stated in the Summary of Product Characteristics (SmPC).
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What it tests

  • Not listed
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Where

12 sites
Novartis Investigative Site
Alessandria, Italy
Novartis Investigative Site
Avellino, Italy
Novartis Investigative Site
Brescia, Italy
Novartis Investigative Site
Florence, Italy
Novartis Investigative Site
Genova, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Palermo, Italy

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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