Long-term Safety of Danicopan: IPIG Registry-based Cohort Study

Study Identifier:
D7332R00004
ClinicalTrials.gov Identifier:
NCT07413679
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Paroxysmal Nocturnal Hemoglobinuria
  • PNH
Study Drug
  • Drug: Danicopan
Date
Aug 2025 - Jul 2029
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Adult participants aged ≥ 18 years at danicopan treatment initiation (baseline) as add-on therapy to ravulizumab/eculizumab.
  • Initiated treatment with danicopan on or after registry enrollment
Exclusion Criteria
  • Participants without known year of birth, sex, informed consent date, or treatment status of danicopan and ravulizumab and/or eculizumab treatment status.
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Paroxysmal Nocturnal Hemoglobinuria
  • PNH
Study Drug
  • Drug: Danicopan
Date
Aug 2025 - Jul 2029
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Adult participants aged ≥ 18 years at danicopan treatment initiation (baseline) as add-on therapy to ravulizumab/eculizumab.
  • Initiated treatment with danicopan on or after registry enrollment
Exclusion Criteria
  • Participants without known year of birth, sex, informed consent date, or treatment status of danicopan and ravulizumab and/or eculizumab treatment status.

Protocol Summary

This is a noninterventional cohort study using primary and secondary data from the International PNH Interest Group (IPIG) PNH registry. It is designed to characterize the long-term safety and tolerability of danicopan as add-on therapy to eculizumab or ravulizumab in adult participants with PNH.

Trial Locations

Location
Status
Location
Alexion Pharmaceuticals, Inc. (Sponsor)
Boston, Massachusetts, United States, 02210
Status
N/A