This is a post-marketing surveillance study conducted as part of the Risk Management Plan (RMP) for South Korea, to evaluate the safety and effectiveness of iptacopan in real-world clinical settings for the treatment of either PNH or C3G in Korean patients. Prospective data will be collected from patient medical records to address the objectives for all eligible populations.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence Rate of Adverse Events (AE), Serious Adverse Events (SAE), and Adverse Drug Reactions (ADR) — Up to 2 years Incidence rate of all AE/ADR, SAE/serious adverse drug reactions (SADR), unexpected AE/ADR, and unexpected SAE/SADR that occur after the administration of iptacopan.
Trial sites (3)
Facility
City
Region
Status
Novartis Investigative Site
Jeollanam
South Korea
Recruiting
Novartis Investigative Site
Seoul
South Korea
Recruiting
Novartis Investigative Site
Seoul
South Korea
Recruiting
More Novartis Pharmaceuticals trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.