Last Update: Jun 26, 2026 A Post-marketing Surveillance of Fabhalta® (Iptacopan) in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) or C3 Glomerulopathy (C3G) ClinicalTrials.gov Identifier: [NCT07416162](https://clinicaltrials.gov/ct2/show/NCT07416162) Novartis Reference Number:CLNP023C1KR01 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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. Condition Paroxysmal Nocturnal Hemoglobinuria, C3 Glomerulopathy Overall Status Recruiting Number of Participants21 Start Date Jun 15, 2026 Completion Date Feb 01, 2029 Gender All Age(s) 18 Years - 99 Years (Adult, Older Adult) ## 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. South Korea #### Novartis Investigative Site Recruiting Jeollanam,519763,South Korea #### Novartis Investigative Site Recruiting Seoul,03080,South Korea #### Novartis Investigative Site Recruiting Seoul,06591,South Korea ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: