A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
A Post-marketing Surveillance of Fabhalta® (Iptacopan) in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) or C3 Glomerulopathy (C3G)
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Incidence Rate of Adverse Events (AE), Serious Adverse Events (SAE), and Adverse Drug Reactions (ADR)
Time frame: Up to 2 years
Secondary Endpoints
Hemoglobin Levels
Lactate Dehydrogenase (LDH) levels
White Blood Cell Count (WBC)
Eligibility Criteria
Inclusion criteria: 1. Patients aged 18 years or older who have been diagnosed with PNH or C3G. 2. Patients who have received vaccination in accordance with the approved Korean labeling prior to initiating treatment with iptacopan. 3. Patients who are being treated or will be treated with iptacopan in accordance with the approved Korean labeling. 4. Patients who have voluntarily provided consent for study participation (written informed consent). Exclusion criteria: 1. Patients who fall under the contraindications for iptacopan administration according to approved Korean labeling. 2. Patients for whom iptacopan administration is deemed inappropriate based on the investigator's judgment.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →