Clinical Trials Logo
  1. Home
  2. Hemophilia B
  3. NCT01233440

Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B

Hemophilia B Clinical Trial

Official title:
An Open-label, Multicenter, Dose-Escalation Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

Clinical Trial Summary

The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.

Clinical Trial Description

This study is comprised of both a rIX-FP dose-escalation safety segment (25, 50 and 75 IU/kg of rIX-FP), and PK evaluation of rIX-FP after a single dose of 50 IU/kg, as well as PK evaluation after a single dose of 50 IU/kg of the previously given Factor IX (FIX) product (recombinant FIX [rFIX] or plasma derived FIX [pdFIX]) which is used as the reference product. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01233440
Study type Interventional
Source CSL Behring
Contact
Status Completed
Phase Phase 1
Start date October 2010
Completion date July 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT04072237 - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia Phase 1
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
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
Not yet recruiting NCT06014320 - Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease