A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
Qualifiers
Patients aged 18 years or older who have been diagnosed with PNH or C3G.
Patients who have received vaccination in accordance with the approved Korean labeling prior to initiating treatment with iptacopan.
Patients who are being treated or will be treated with iptacopan in accordance with the approved Korean labeling.
Patients who have voluntarily provided consent for study participation (written informed consent).
Disqualifiers
Patients who fall under the contraindications for iptacopan administration according to approved Korean labeling.
Patients for whom iptacopan administration is deemed inappropriate based on the investigator's judgment.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
21 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov