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

N/ANot Yet RecruitingNCT07416162

Novartis Pharmaceuticals21 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Paroxysmal Nocturnal Hemoglobinuria C3 Glomerulopathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Incidence rate of all AE/ADR, SAE/serious adverse drug reactions (SADR), unexpected AE/ADR, and unexpected SAE/SADR that occur after the administration of iptacopan.

Time frame: Up to 2 years