This clinical study was sponsored by Octapharma AG, Lachen, Switzerland.
Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers
Article first published online: 16 JAN 2013
© 2013 American Association of Blood Banks
Volume 53, Issue 9, pages 1906–1917, September 2013
How to Cite
Jilma-Stohlawetz, P., Kursten, F. W., Horvath, M., Leitner, G., List, J., Marcek, J., Quehenberger, P., Schwameis, M., Bartko, J., Derhaschnig, U. and Jilma, B. (2013), Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers. Transfusion, 53: 1906–1917. doi: 10.1111/trf.12075
- Issue published online: 9 SEP 2013
- Article first published online: 16 JAN 2013
- Manuscript Accepted: 1 OCT 2012
- Manuscript Revised: 25 SEP 2012
- Manuscript Received: 1 DEC 2011
Octaplas LG is a prion-depleted version of a previous generation product called Octaplas S/D. We compared the recovery, safety, and tolerability of these two pharmaceutical-grade plasmas.
Study Design and Methods
In this comparative, block-randomized, open-label, active-controlled, crossover Phase I trial, 60 healthy adult volunteers received single transfusions of 1200 mL of parent product (in Period 1) and of the LG plasma product (in Period 2) or vice versa. In both periods, plasmapheresis (600 mL) preceded the transfusion. Blood samples were drawn before and after apheresis and 15 minutes, 2 hours, 24 hours, and 7 days after end of plasma transfusion, to assess recovery, safety, and tolerability. The primary efficacy endpoints were the changes in coagulation factors and hemostatic variables compared to baseline; their relative recovery was computed in the per-protocol analysis (n = 43). Safety and tolerability were assessed (n = 60).
Variations in coagulation factors and hemostatic variables over time were similar between the two treatments and within normal range; 90% confidence intervals for the derived recovery data were within predefined limits of equivalence. Both products were well tolerated. The advanced manufacturing process also significantly increased plasmin inhibitor concentrations after transfusion in vivo.
The LG plasma product was bioequivalent to its predecessor with respect to recovery of clotting factors and demonstrated comparable safety and tolerability in healthy volunteers. Both products compensated well for the loss of clotting factors after apheresis (NCT01063595).