drugset / Trial / NCT01938378

Octaplas Pediatric Plasma Exchange Trial

NCT01938378

Phase 4 Completed 41 enrolled Octapharma
NaSingle-groupOpen-labelTreatment

Summary

To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric patients who require therapeutic plasma exchange.

Timeline

Start
2015-04
Primary completion
2019-01-27
Completion
2019-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Octaplas LG Other / unclassified 40 unknown Intravenous
Subject Octaplas LG Other / unclassified 60 unknown Intravenous

Indications

No indication recorded.