Clinical Trials in Spain / NCT05389449
Active, not recruiting
Phase 3
A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH
NCT05389449 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Paroxysmal Nocturnal Hemoglobinuria
Study summary
This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.
Eligibility
Key Inclusion Criteria:
* All participants who completed their participation in an Alexion sponsored clinical study with danicopan as an add on to a C5i treatment.
* Patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
* Documentation of vaccination for Neisseria meningitidis: All participants must be revaccinated as per national vaccination guidelines or local practice for vaccination use with complement inhibitors.
Key Exclusion Criteria:
* Any medical condition (for example, cardiac, pulmonary, renal, oncologic, or psychiatric) that, in the opinion of the Investigator, might interfere with participation in the study, pose any added risk to the participant, or confound the assessment of the participant.
* Patient has been permanently discontinued from danicopan in the parent study for any reason other than enrollment into this LTE study.
* Female participants who are pregnant, breastfeeding, or intending to conceive during the course of the study.
Primary outcome measure(s)
- Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs — Up to 3 years
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Los Angeles | California | |
| Research Site | Chicago | Illinois | |
| Research Site | Baltimore | Maryland | |
| Research Site | Kansas City | Missouri | |
| Research Site | Long Island City | New York | |
| Research Site | Cleveland | Ohio | |
| Research Site | Dallas | Texas | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Rio de Janeiro | Brazil | |
| Research Site | Toronto | Ontario | |
| Research Site | Brno | Czechia | |
| Research Site | Lille | France | |
| Research Site | Paris | France | |
| Research Site | Pessac | France | |
| Research Site | Pierre-Bénite | France | |
| Research Site | Athens | Greece | |
| Research Site | Thessaloniki | Greece | |
| Research Site | Haifa | Israel | |
| Research Site | Jerusalem | Israel | |
| Research Site | Avellino | Italy | |
| Research Site | Bassano del Grappa | Italy | |
| Research Site | Florence | Italy | |
| Research Site | Milan | Italy | |
| Research Site | Reggio Calabria | Italy | |
| Research Site | Roma | Italy | |
| Research Site | Bunkyō City | Japan | |
| Research Site | Kyoto | Japan | |
| Research Site | Osaka | Japan | |
| Research Site | Shibuya-ku | Japan | |
| Research Site | Tsukuba | Japan | |
| Research Site | Kota Kinabalu | Malaysia | |
| Research Site | Kuching | Malaysia | |
| Research Site | Miri | Malaysia | |
| Research Site | Gdansk | Poland | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Suwon | South Korea | |
| Research Site | Badalona | Spain | |
| Research Site | Barcelona | Spain | |
| Research Site | Majadahonda | Spain |
+ 5 more sites — see the full list on the official registry below.
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05389449 on ClinicalTrials.gov ↗ ← All trials in Spain