Post-authorization Safety Study of Iptacopan in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Using Data From the IPIG PNH Registry
Post-authorization Safety Study of Iptacopan in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Using Data From the Non-interventional IPIG PNH Registry
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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.
Cumulative incidence of infections (event probability as a function of time), caused by encapsulated bacteria
Time frame: From initiation of iptacopan until discontinuation + 3 days, or end of follow-up, up to 5 years.
Number of patients with infections events per 100 participants -years (incidence rates) caused by encapsulated bacteria
Time frame: From initiation of iptacopan until discontinuation + 3 days, or end of follow-up, up to 5 years.
Number of infections episodes per 100 patients -years (occurrence rates) caused by encapsulated bacteria
Time frame: From initiation of iptacopan until discontinuation + 3 days, or end of follow-up, up to 5 years.
Secondary Endpoints
Number of patients with serious infections caused by encapsulated bacteria and all serious infection
Cumulative incidence of serious infections, caused by encapsulated bacteria and all serious infection (event probability as a function of time)
Number of patients with serious infections events per 100 patients -years (incidence rates) caused by encapsulated bacteria and all serious infection
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
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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