NCT07416162Recruiting
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)
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 21 (estimated)
- First submitted
- 11 Feb 2026
- Start date
- Jun 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- Novartis Pharmaceuticals
- NCT number
- NCT07416162
What you commit to
- Study type: Observational
- Planned participants: 21
- From Jun 2026 to the primary completion date, Feb 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Jeollanam | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.