drugset / Trial / NCT03091751

Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B

NCT03091751 ↗

Phase 2 Completed 13 enrolled Grifols Biologicals, LLC
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-08
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BeneFIX Protein / enzyme biologic 65 iu/kg —
Subject BeneFIX Protein / enzyme biologic 75 iu/kg —

Indications