NCT00768287

Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Medexus Pharma, Inc. · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the safety (acute effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis and with respect to control of hemorrhaging in both the prophylaxis and on demand groups of IB1001 in subjects with hemophilia B. Key Secondary Objectives: To evaluate the ability of IB1001 to provide coverage against bleeding under surgical circumstances; To evaluate the long-term safety and efficacy of IB1001

Conditions

• Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	IB1001	Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa; Study Part 2: Non-randomized, open-label evaluation of prophylaxis and on demand IB1001; Surgical Sub-study: Open-label evaluation of IB1001 during major surgery
BIOLOGICAL	nonacog alfa	Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-03-01
• Completion: 2016-12-01
• First posted: 2008-10-08
• Last updated: 2021-04-06
• Results posted: 2018-09-10

Locations

23 sites across 7 countries: United States, France, India, Israel, Italy, Poland, United Kingdom