Anemia Clinical Trials

Find Anemia Clinical Trials Near You

A Post-marketing Surveillance of Fabhalta® (Iptacopan) in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) or C3 Glomerulopathy (C3G)

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Republic of Korea
Novartis Investigative Site
RECRUITING
Jeollanam
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2026-06-15
Estimated Completion Date: 2029-02-01
Participants
Target number of participants: 21
Treatments
PNH Cohort
Patients in South Korea who receive at least one dose of iptacopan for the treatment of PNH.
C3G Cohort
Patients in South Korea who receive at least one dose of iptacopan for the treatment of C3G.
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov