Who is sponsoring NCT01063595?

NCT01063595 is sponsored by Octapharma.

What condition does NCT01063595 study?

NCT01063595 studies Comparison of Octaplas LG and Octaplas SD.

What drugs are being tested in NCT01063595?

Interventions: Octaplas LG, Octaplas SD.

What is the status of NCT01063595?

NCT01063595 is currently COMPLETED.

Last reviewed 2014-05-12 · How we verify

A Comparative, Open-label, Randomized, Cross-over Phase I Trial in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability of Octaplas LG™ vs. Octaplas®

NCT01063595 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Octapharma
Phase	Phase 1
Status	COMPLETED
Enrolment	63
Start date	2009-12
Completion	2010-07

Conditions

Comparison of Octaplas LG and Octaplas SD

Interventions

Octaplas LG
Octaplas SD

Primary outcomes

Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI — From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.
Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C — From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.

Countries

Austria