rIX-FP Subct
/ CSL Behring
- LARVOL DELTA
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November 12, 2025
Safety, Efficacy and Treatment Patterns of rIX-FP in Previously Untreated Paediatric Haemophilia B Patients: A Retrospective Chart Review in Japan.
(PubMed, Haemophilia)
- "This study provides real-world insights into rIX-FP use in paediatric PUPs, demonstrating its favourable safety, effective prophylaxis, and lower IVR in infants."
Journal • Retrospective data • Hematological Disorders • Hemophilia • Hemophilia B • Pediatrics • Rare Diseases
July 18, 2024
Characterization of recombinant Factor IX fusion proteins enabling subcutaneous administration.
(PubMed, J Thromb Haemost)
- "rIX(R338L)-FP was shown to be a promising candidate for SC administration, exhibiting increased specific activity combined with higher activity-based exposure, and indicating efficacy at lower protein dose."
Journal • Hematological Disorders • Hemophilia • Rare Diseases
June 30, 2021
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
(clinicaltrials.gov)
- P3b; N=95; Completed; Sponsor: CSL Behring; Active, not recruiting ➔ Completed
Clinical • Trial completion • Hematological Disorders • Hemophilia • Rare Diseases
January 08, 2021
[VIRTUAL] ANALYSIS OF EXTENDED DOSING REGIMENS WITH RECOMBINANT COAGULATION FACTOR IX ALBUMIN FUSION PROTEIN (RIX‐FP) IN ADULT AND PAEDIATRIC PATIENTS WITH HAEMOPHILIA B: A POPULATION PHARMACOKINETIC SIMULATION
(EAHAD 2021)
- "FIX activity-time profiles for different extended dosing intervals can be predicted using the PPK model. The PPK simulation data suggest that most adult and paediatric patients with haemophilia B receiving rIX-FP on 21-day and 14-day extended interval dosing regimens, respectively, could reach adequate FIX activity levels associated with a mild or moderate haemophilia classification as seen in the clinical trial."
Clinical • PK/PD data • Hematological Disorders • Hemophilia • Pediatrics • Rare Diseases
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