NCT02053792

A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B

A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: CSL Behring · Industry
• Sex: Male
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study. A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.

Conditions

• Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	rIX-FP	Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)

Timeline

• Start date: 2014-02-06
• Primary completion: 2021-06-02
• Completion: 2021-06-02
• First posted: 2014-02-04
• Last updated: 2022-07-14
• Results posted: 2022-07-14

Locations

42 sites across 15 countries: United States, Australia, Austria, Bulgaria, Canada, Czechia, France, Germany, Israel, Italy, Japan, Malaysia, Philippines, South Africa, Spain