Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B
Summary
This trial is conducted in Europe, Japan and the United States of America (USA).
The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX in Non-Bleeding Patients with Haemophilia B.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Haemophilia B
Intervention
40K PEG-rFIX, 40K PEG-rFIX, 40K PEG-rFIX
Location
Novo Nordisk Clinical Trial Call Center
Ann Arbor
Michigan
United States
48109-5235
Status
Active, not recruiting
Source
Novo Nordisk
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00956345
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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PubMed Articles
Post-translational modifications (PTMs) located on the activation peptide (AP) of recombinant FIX (rFIX, BeneFIX(®) ) and plasma-derived FIX (pdFIX, Betafact(®) ) have been investigated by mass spec...
Population pharmacokinetics of recombinant factor IX: implications for dose tailoring.
The principles of pharmacokinetic (PK) dose tailoring in clinical practice, using limited blood sampling and Bayesian PK analysis, have been described for factor VIII (FVIII). This study applied the s...
Haemophilia Care in Europe: the ESCHQoL study.
The aim of this study was to determine the clinical conditions of patients with haemophilia within Europe as recommended by the European Commission. In this multicentre, cross-sectional, ambispective...
