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Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers

Authors

  • Petra Jilma-Stohlawetz,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Friedrich W. Kursten,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Michaela Horvath,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Gerda Leitner,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Jana List,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Jana Marcek,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Peter Quehenberger,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Michael Schwameis,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Johann Bartko,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Ulla Derhaschnig,

    1. Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
    2. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    3. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
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  • Bernd Jilma

    Corresponding author
    1. Department of Emergency Medicine, and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    2. Clinical Research and Development Department, Octapharma Pharmazeutika Produktionsges.m.b.H, Vienna, Austria
    • Department of Blood Group Serology and Transfusion Medicine, Laboratory Medicine, Medical University of Vienna, Vienna, Austria
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  • This clinical study was sponsored by Octapharma AG, Lachen, Switzerland.

Address reprint requests to: Bernd Jilma, MD, Medical Department of Clinical Pharmacology, University of Vienna, Währingergürtel 18-20, 1090 Vienna, Austria; e-mail: Bernd.Jilma@meduniwien.ac.at.

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.

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).

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.

Conclusion

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).

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