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:
Novartis Reference Number:CLNP023C1KR01
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.

Paroxysmal Nocturnal Hemoglobinuria, C3 Glomerulopathy
Recruiting
21
Jun 15, 2026
Feb 01, 2029
All
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.

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