drugset
drugset / Trial / NCT01575756

Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

NCT01575756 ↗

Phase 2 Completed 22 enrolled Octapharma
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency

Timeline

Start
2013-06
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic 70 mg/kg Intravenous
Subject Octafibrin Protein / enzyme biologic 70 mg/kg Intravenous

Indications

congenital afibrinogenemia