A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD

Phase 1 Completed 63 enrolled Octapharma

RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.

Timeline

Start: 2009-12
Primary completion: 2010-07
Completion: 2010-07

Publications

Jilma-Stohlawetz P, Kursten FW, Horvath M, Leitner G, List J, Marcek J, Quehenberger P, Schwameis M, Bartko J, Derhaschnig U, Jilma B. Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers. Transfusion. 2013 Sep;53(9):1906-17. doi: 10.1111/trf.12075. Epub 2013 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Octaplas LG	Other / unclassified	1200 ml	Intravenous
Comparator	Octaplas SD	Other / unclassified	1200 ml	Intravenous

Indications

No indication recorded.