Iptacopan use in Korean patients with PNH or C3G

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects prospective data from patient medical records as part of the Risk Management Plan in South Korea. It aims to describe safety and effectiveness of iptacopan when used per Korean labeling for adults with PNH or C3G. Data will come from patients treated with iptacopan, with consent, to address predefined objectives across eligible populations. The study does not randomize or alter standard clinical care and reflects real-world practice. It is conducted at multiple Novartis investigative sites in Korea.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Jeollanam, South Korea Recruiting
• Novartis Investigative Site
  Seoul, South Korea Recruiting
• Novartis Investigative Site
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral HS-10542 for paroxysmal nocturnal hemoglobinuria

  This study will test whether the oral drug HS-10542 can reduce hemolysis and raise hemoglobin in adults with PNH, including those not fully helped by C5 inhibitor therapy.

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• Danicopan added to ravulizumab or eculizumab for PNH in Korea

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• Pozelimab + cemdisiran for adults with PNH whose current treatment isn't working

  This trial tests whether combining pozelimab and cemdisiran can better reduce hemolysis in adults with PNH whose C5 inhibitor treatment isn’t controlling their disease.

  Recruiting at 20 sites Phase 3 Regeneron Pharmaceuticals · Ribeirão Preto, São Paulo and 19 other locations · NCT07154745

• Home-reported outcomes for people with C3 Glomerulopathy

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• Evaluating MY008211A for treating anemia in PNH patients on anti-C5 therapy

  This study is testing a new treatment called MY008211A to see if it can help people with PNH who still have anemia even while on anti-C5 therapy.

  Recruiting Phase 3 Wuhan Createrna Science and Technology Co., Ltd · Beijing, Beijing Municipality · NCT06932471

• Iptacopan treatment for adults with PNH in China

  This study will try iptacopan (LNP023) in adults with PNH in China to see if it improves clinical and laboratory outcomes and changes healthcare use.

  Recruiting at 14 sites Novartis · Hefei, Anhui and 13 other locations · NCT06931691

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.