Post-authorization Safety Study of Iptacopan in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Using Data From the IPIG PNH Registry
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT06903234
- Status
- Active Not Recruiting
Conditions
- Hemoglobinuria, Paroxysmal
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Iptacopan — DRUGAdult patients with PNH treated with iptacopan
Study Details
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.
Key Dates
- Start date
- Mar 31, 2025
- Status verified
- May 2025
- Primary completion
- Oct 1, 2029
- Completion
- Oct 1, 2029
Study Design
- Enrollment
- 200 participants (estimated)
Arms
- Arm: IptacopanAdult patients with PNH treated with iptacopan in routine care.
Primary Outcome Measure
Number of patients with infections caused by encapsulated bacteria [ Time Frame: From initiation of iptacopan until discontinuation + 3 days, or end of follow-up, up to 5 years. ]