A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH

Study Identifier:
ALXN2040-PNH-303
ClinicalTrials.gov Identifier:
NCT05389449
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
Study Drug
  • Drug: Danicopan
Date
Oct 2022 - Jul 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
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.
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.
Sex
Female & Male
Age
N/A

Study Details

Medical Condition
  • Paroxysmal Nocturnal Hemoglobinuria
Study Drug
  • Drug: Danicopan
Date
Oct 2022 - Jul 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A years
Requirements Information
Inclusion and Exclusion Criteria
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.
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.

Protocol 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.

Trial Locations

Location
Status
Location
Research Site
Los Angeles, California, United States, 90089
Status
N/A
Location
Research Site
Chicago, Illinois, United States, 60612
Status
N/A
Location
Research Site
Baltimore, Maryland, United States, 21231
Status
N/A
Location
Research Site
Kansas City, Missouri, United States, 64111
Status
N/A
Location
Research Site
Long Island City, New York, United States, 11101
Status
N/A
Location
Research Site
Cleveland, Ohio, United States, 44195
Status
N/A
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