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NCT06903234
Post-authorization Safety Study of Iptacopan in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Using Data From the IPIG PNH Registry
Conditions: Hemoglobinuria, Paroxysmal
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 200
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Basel
Summary
This is an observational single-arm descriptive cohort study based on the secondary use of data collected on iptacopan-treated patients with paroxysmal nocturnal hemoglobinuria (PNH) through the International PNH Interest Group (IPIG) PNH registry.
Eligibility Criteria
Inclusion Criteria:
* Signed informed consent to participate in the IPIG PNH Registry
* PNH confirmed by flow cytometry
* Incident users of iptacopan
* Aged at least 18 years at the iptacopan initiation
Exclusion Criteria:
* Participation in an interventional clinical trial
Source: ClinicalTrials.gov (NCT06903234). StuddyBuddy aggregates publicly available trial information.