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

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Paroxysmal Nocturnal Hemoglobinuria, C3 Glomerulopathy

Countries: South Korea

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (3)

Jeollanam, South Korea
Seoul, South Korea
Seoul, South Korea