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

Hemophilia B Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00768287
Study type Interventional
Source Medexus Pharma, Inc.
Contact
Status Completed
Phase Phase 2/Phase 3
Start date January 2009
Completion date December 2016
View Details
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