At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
BeneFIXdrug
Likely dose
BeneFIX 75 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Factor IX (FIX) Contained in AlphaNine® and Its Pharmacokinetic Comparison With BeneFIX® in Patients With Severe Hereditary Haemophilia B
In Brief
A Phase 2 clinical trial evaluating BeneFIX for Hemophilia B. Completed, enrolled 13 participants across 3 sites.
Detailed Summary
The goal of this non-randomized, multi-center study in subjects with severe hereditary haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX in subjects having had 2 prior pharmacokinetic assessments with AlphaNine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesBulgaria
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2005
Primary CompletionOct 2009
First PostedMar 2017
TodayJul 2026
First PostedMar 27, 2017
Enrollment StartAug 1, 2005
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.3 years ago
Interventions
BeneFIXdrug
BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg.