Long-term Safety of Danicopan: IPIG Registry-based Cohort Study
NCT07413679 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2026-02-17
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.
Conditions
Interventions
- DRUG
-
Danicopan
Participants will receive Danicopan as an add-on therapy.
Sponsors & Collaborators
-
Alexion Pharmaceuticals, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-18
- Primary Completion
- 2029-07-01
- Completion
- 2029-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT07266155 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Danicopan Early Access Program
NCT05982938 ·Status: AVAILABLE
-
The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
NCT00438789 ·Status: APPROVED_FOR_MARKETING
-
A Long-Term Treatment Study of ACH-0144471 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT03181633 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Escalation of BCX10013 in Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT06100900 ·Status: COMPLETED ·Phase: PHASE1
-
Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria
NCT06238544 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
NCT05886244 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
NCT05876312 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Dynepo Long-Term Safety Study
NCT00514813 ·Status: TERMINATED ·Phase: PHASE4
-
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera
NCT03287245 ·Status: TERMINATED ·Phase: PHASE2
-
Eculizumab in Treating Patients With Paroxysmal Nocturnal Hemoglobinuria
NCT00112983 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT07256301 ·Status: RECRUITING ·Phase: PHASE1
-
Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria
NCT06051357 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT01335165 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early Hemodialysis Patients
NCT00261521 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
NCT06593938 ·Status: COMPLETED ·Phase: PHASE3
-
Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients
NCT00701714 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
NCT00090753 ·Status: COMPLETED ·Phase: PHASE3
-
COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.
NCT00377481 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects
NCT00117247 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.
NCT00752609 ·Status: COMPLETED ·Phase: PHASE2
-
Darbepoetin Alfa Treatment of Anemia in Hemodialysis Subjects
NCT00119587 ·Status: COMPLETED ·Phase: PHASE3
-
Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure
NCT00213291 ·Status: COMPLETED ·Phase: PHASE3
-
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
NCT02021318 ·Status: COMPLETED ·Phase: PHASE3
-
European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
NCT00838097 ·Status: COMPLETED