drugset
drugset / Trial / NCT03899142

Pharmacokinetics of New HepBQuin

NCT03899142 ↗

Phase 1 Completed 24 enrolled Prothya Biosolutions
NaSingle-groupOpen-labelOther

Summary

Sanquin Plasma Products BV developed a new manufacturing process for the Quin plasma products in order to improve viral safety and to remove procoagulant activity. Since the new manufacturing process will be the same for all Quin products, a clinical study with one of the Quin products is sufficient for marketing authorisation of all new Quin products. HepBQuin will serve as model for all other Quin products. Pharmacokinetic (PK) data are considered as a surrogate indicator of efficacy.

Timeline

Start
2019-03-20
Primary completion
2019-07-04
Completion
2019-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HepBQuin Protein / enzyme biologic — Intramuscular

Indications

No indication recorded.