Specified Drug-use Surveillance of Fabhalta Capsules
NCT06606314 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 132
Last updated 2026-05-22
Summary
This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.
Conditions
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Eligibility
- Min Age
- 0 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-18
- Primary Completion
- 2028-09-30
- Completion
- 2028-09-30
Countries
- Japan
Study Locations
More Related Trials
-
Assessment of the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Renal Impairment
NCT01406340 ·Status: TERMINATED ·Phase: PHASE1
-
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
NCT00548691 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT03946748 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease
NCT02019719 ·Status: COMPLETED ·Phase: PHASE2
-
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
NCT01521494 ·Status: COMPLETED ·Phase: PHASE2
-
A First-in-Human Safety and Efficacy Study of ALN-CFB, a Small Interfering RNA (siRNA) Targeting Complement Factor B, in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria With Persistent Anemia on a C5 Inhibitor
NCT07187401 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria
NCT02534909 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function
NCT05711381 ·Status: COMPLETED ·Phase: PHASE1
-
A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)
NCT05515367 ·Status: RECRUITING ·Phase: PHASE4
-
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
NCT01244763 ·Status: COMPLETED ·Phase: PHASE2
-
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
NCT03054337 ·Status: COMPLETED ·Phase: PHASE2
-
Single Dose Safety Study for Compound to Treat Anemia in Patients With Renal Impairment
NCT00935831 ·Status: COMPLETED ·Phase: PHASE1
-
REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.
NCT04162470 ·Status: TERMINATED ·Phase: PHASE3
-
Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria
NCT00130000 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction
NCT00483600 ·Status: WITHDRAWN ·Phase: NA
-
Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
NCT01414075 ·Status: COMPLETED ·Phase: PHASE2
-
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
NCT03832114 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT03053102 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients
NCT07177859 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Evaluation of the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vasculopathy of the Graft in de Novo Renal Transplant Patients Transplant
NCT00565474 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Severe Impaired Renal Function
NCT02840812 ·Status: UNKNOWN ·Phase: PHASE1
-
PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function
NCT04656795 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics of HSK21542 in Subjects With Renal Impairment
NCT05947097 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
NCT00596518 ·Status: COMPLETED ·Phase: PHASE1
-
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants Not Receiving Other Complement Inhibitor Therapy
NCT05116787 ·Status: TERMINATED ·Phase: PHASE2