title: Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers.
abstract: BACKGROUND
  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.
  
  
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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).
authors: Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria; Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria; Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria.
authors: Petra
authors: P
authors: Jilma-Stohlawetz
authors: Friedrich W
authors: FW
authors: Kursten
authors: Michaela
authors: M
authors: Horvath
authors: Gerda
authors: G
authors: Leitner
authors: Jana
authors: J
authors: List
authors: Jana
authors: J
authors: Marcek
authors: Peter
authors: P
authors: Quehenberger
authors: Michael
authors: M
authors: Schwameis
authors: Johann
authors: J
authors: Bartko
authors: Ulla
authors: U
authors: Derhaschnig
authors: Bernd
authors: B
authors: Jilma
mesh_terms: D000328:Adult; D016913:Blood Component Transfusion / Q000009:adverse effects* / Q000379:methods*; D018592:Cross-Over Studies; D003902:Detergents / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010949:Plasma / Q000187:drug effects*; D012997:Solvents / Q000494:pharmacology*
chemical_list: D003902:Detergents; D012997:Solvents