drugset
drugset / Trial / NCT02281500

Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia

NCT02281500 ↗

Phase 1/2 Completed 24 enrolled Grifols Therapeutics LLC Instituto Grifols, S.A. · collab
NaSingle-groupOpen-labelTreatment

Summary

The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight administration.

Timeline

Start
2016-07-22
Primary completion
2019-11-11
Completion
2019-11-11

Drugs

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

Indications

congenital afibrinogenemia