NCT07416162 A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
| NCT ID | NCT07416162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Paroxysmal Nocturnal Hemoglobinuria |
| Study Type | OBSERVATIONAL |
| Enrollment | 21 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 21 participants in total. It began in 2026-06-15 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07416162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Paroxysmal Nocturnal Hemoglobinuria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07416162 currently recruiting?
Yes, NCT07416162 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07416162 trial being conducted?
This trial is being conducted at Jeollanam, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT07416162 clinical trial?
NCT07416162 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 21 participants.