Study of Recombinant Factor IX Product, IB1001, in Previously Treated

Clinical Trial Summary

The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and control of hemorrhaging during prophylaxis) of IB1001 in previously treated pediatric subjects with hemophilia B.

See also
Status	Clinical Trial	Phase
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Completed	`NCT02199717` - An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia	N/A
Completed	`NCT01662531` - A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B	Phase 3
Completed	`NCT01335061` - Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B	Phase 3
Completed	`NCT01217255` - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed	`NCT00037557` - Study Evaluating rFIX; BeneFIX in Severe Hemophilia B	Phase 3
Completed	`NCT02554773` - An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B	Phase 1/Phase 2
Terminated	`NCT02807753` - The Hemophilia Ultrasound Project
Active, not recruiting	`NCT03901755` - An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
Not yet recruiting	`NCT05980377` - Patterns of Hemophilia Care in Assiut Children Patients
Recruiting	`NCT05687474` - Baby Detect : Genomic Newborn Screening
Terminated	`NCT03248141` - Understanding Hemophilia A and B Drug Dosage Administration Patterns
Terminated	`NCT01460147` - Osteoporosis and MRI Study in Hemophilia	N/A
Completed	`NCT03818529` - ATHN 8: Previously Untreated Patients (PUPs) Matter Study
Completed	`NCT02571569` - A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors	Phase 1
Terminated	`NCT01620801` - Hemophilia B Gene Therapy With AAV8 Vector	Phase 1
Completed	`NCT01233440` - Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B	Phase 1
Active, not recruiting	`NCT04135300` - Gene Therapy for Chinese Hemophilia B	N/A
Enrolling by invitation	`NCT03655223` - Early Check: Expanded Screening in Newborns
Terminated	`NCT00947193` - Study of Ataluren (PTC124) in Hemophilia A and B	Phase 2

NCT number	NCT01271868
Study type	Interventional
Source	Medexus Pharma, Inc.
Contact
Status	Terminated
Phase	Phase 3
Start date	November 2010
Completion date	December 2016

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms