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Clinical Trials in Italy / 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 Italy tracker
Phase
Phase 3
Started
2022-10-28
Last updated
2026-06-18

Condition(s) studied

Paroxysmal Nocturnal Hemoglobinuria

Investigational drug(s) / intervention(s)

Danicopan →

Danicopan: Oral tablet

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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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)

Trial sites (45)

FacilityCityRegionStatus
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.

More Alexion Pharmaceuticals, Inc. trials in Italy

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 Italy