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Active Not RecruitingNCT07413250

Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis of IPIG-Registry Data

A Study to Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis of International PNH Interest Group (IPIG)-Registry Data

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Alexion Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a noninterventional registry-based cohort study utilizing data collected on danicopan-treated patients with paroxysmal nocturnal hemoglobinuria (PNH) through the International PNH Interest Group (IPIG) PNH registry. The primary objectives seek to characterize the long-term safety profile of danicopan as add-on therapy to ravulizumab/eculizumab in participants with PNH.

Conditions

Interventions

TypeNameDescription
DRUGDanicopanParticipants treated with danicopan as an add-on therapy.
DRUGSoliris/UltomirisParticipants treated with Soliris/Ultomiris monotherapy.

Timeline

Start date
2026-01-14
Primary completion
2030-01-15
Completion
2030-01-15
First posted
2026-02-17
Last updated
2026-02-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07413250. Inclusion in this directory is not an endorsement.