Danicopan added to ravulizumab or eculizumab for PNH in Korea
Official title: Danicopan Regulatory Post-Marketing Study in Korea
Run by AstraZeneca · NCT07457151 · Data updated 2026-11-12
This will see if adding Danicopan to ravulizumab or eculizumab is safe and helps people with PNH who are treated in routine care in Korea.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 27 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | Eculizumab, Ravulizumab |
| Locations | 4 sites (Busan and 3 other locations) |
| Status | Recruiting |
| Started | April 10, 2026 |
| Main results expected | June 27, 2028 |
| Study ends | June 27, 2028 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07457151 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients with PNH in Korea who are eligible for and prescribed Danicopan as an add-on to eculizumab or ravulizumab and who provide informed consent are ideal candidates.
✕Probably not a fit
Patients not receiving Danicopan, those on other off-label indications, or those enrolled in concurrent interventional trials are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a post-approval, observational program in Korea to collect real-world safety and effectiveness data on Danicopan when used as an add-on to C5 inhibitors (eculizumab or ravulizumab) for patients with paroxysmal nocturnal hemoglobinuria. Patients prescribed Danicopan in routine clinical practice at participating sites will be followed and data on adverse events, hemoglobin levels, transfusion need, and other effectiveness measures at around 12 weeks will be recorded. The study is non-interventional and designed to detect known safety signals or previously unrecognized adverse reactions under normal care conditions. Results will inform local post-marketing safety and usage patterns for Danicopan in Korea.
Why it matters
Potential benefit: If successful, this could confirm that adding Danicopan improves anemia control and reduces transfusion needs for some PNH patients already on a C5 inhibitor.
How similar studies have gone: Prior clinical trials of danicopan have shown improvements in hemolysis and hemoglobin as an add-on to C5 inhibitors, but real-world data in Korean clinical practice are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients eligible for and treated with Danicpan as add-on therapy to a C5 inhibitor (Eculizumab or Ravulizumab) in patient with PNH in Korea 2. Provision of a signed and dated written informed consent by the patient or their legally acceptable representative Exclusion Criteria: 1. Participation in any concurrent interventional trials during the period of study drug treatment 2. Other off-label indications according to the approved label in Korea
Where it's running
-
Research Site
Busan, South Korea Recruiting -
Research Site
Hwasun-gun, South Korea Recruiting -
Research Site
Seoul, South Korea Recruiting -
Research Site
Seoul, South Korea Active not recruiting
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
-
Iptacopan use in Korean patients with PNH or C3G
This post-marketing surveillance study tests how well iptacopan works and how safe it is for Korean adults with PNH or C3G in real-world care.
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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.
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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.
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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.
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Long-term safety and tolerability of HSK39297 for patients with PNH
This study is testing if continuing treatment with HSK39297 is safe and effective for adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have already used this medication.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.