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

PHASE1CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Comparison of Octaplas LG and Octaplas SD
Interventions
BIOLOGICAL

Octaplas LG

Octaplas LG was composed of human coagulation-active plasma treated with solvent/detergent for 1-1.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. An additional manufacturing step, involving an affinity ligand gel, removed prion proteins. Octaplas LG was provided frozen in pyrogen free plastic bags.

BIOLOGICAL

Octaplas SD

Octaplas SD was composed of human coagulation-active plasma treated with solvent/detergent for 4-4.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. Octaplas SD was provided frozen in pyrogen free plastic bags.

Trial Locations (1)

Unknown

Department of Clinical Pharmacology - Medical University Vienna, Vienna

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY