Not Yet RecruitingNot Applicable

A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy

21 participantsStarted 2026-07-31

Plain-language summary

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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

Incidence Rate of Adverse Events (AE), Serious Adverse Events (SAE), and Adverse Drug Reactions (ADR)

Timeframe: Up to 2 years

Trial details

NCT IDNCT07416162

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-02-01

Contact for this trial

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

View on ClinicalTrials.gov More Paroxysmal Nocturnal Hemoglobinuria trials