Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab
Study Identifier:
ACH471-101
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Danicopan
- Drug: Eculizumab
Date
May 2018 - Sep 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Sex
Female & Male
Age
18 - 65 Years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Danicopan
- Drug: Eculizumab
Date
May 2018 - Sep 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years years
Requirements Information
Protocol Summary
To determine the effectiveness of ACH-0144471 (also known as danicopan and ALXN2040) in improving anemia when given with eculizumab for 24 weeks in participants with PNH. Danicopan dose may be increased within each participant, to a maximum of 200 milligrams (mg) three times daily (TID) based on safety and efficacy at protocol-specified time points.
Trial Locations
Location
Status
Location
Clinical Study Site
Baltimore, Maryland, United States, 21287
Status
N/A
Location
Clinical Study Site
Cleveland, Ohio, United States, 44195
Status
N/A
Location
Clinical Study Site
Florence, Italy
Status
N/A
Location
Clinical Study Site
Naples, Italy
Status
N/A
Location
Clinical Study Site
London, United Kingdom
Status
N/A