Status:
ACTIVE_NOT_RECRUITING
Post-authorization Safety Study of Iptacopan in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Using Data From the IPIG PNH Registry
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hemoglobinuria, Paroxysmal
Eligibility:
All Genders
18-100 years
Brief 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 Inter...
Detailed Description
This multinational, non-interventional, descriptive single-arm cohort study is based on secondary analysis of data collected within the iptacopan silo of the IPIG PNH Registry (data on iptacopan-treat...
Eligibility Criteria
Inclusion
- 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
- Participation in an interventional clinical trial
Key Trial Info
Start Date :
March 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06903234
Start Date
March 31 2025
End Date
October 1 2029
Last Update
May 15 2025
Active Locations (1)
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1
Novartis Investigative Site
Basel, Switzerland