A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
Condition: Comparison of Octaplas LG and Octaplas SD
Intervention: Octaplas LG; Octaplas SD
Intervention description: 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.; 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Octaplas LG; Octaplas SD

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of understanding and complying with all aspects of the protocol.

          -  Signed Informed Consent.

          -  Capable of understanding the plasmapheresis information sheet and sign it.

          -  Healthy male or female volunteers, age 18 years or older.

          -  Women must have negative pregnancy test (human chorionic gonadotropin [HCG] based
             assay).

          -  Women must have sufficient methods of contraception (eg, intrauterine device, oral
             contraception, etc).

          -  No clinically relevant abnormalities in medical history and general physical
             examination.

          -  Standard health insurance.

        Exclusion Criteria:

          -  Pregnancy or lactation.

          -  Tattoos within the last 3 months.

          -  Subject was treated therapeutically with fresh frozen plasma, blood, or plasma-derived
             products within the last 6 months.

          -  Hypersensitivity to blood products or plasma proteins.

          -  History of angioedema.

          -  History of coagulation or bleeding disorder or any other known abnormality affecting
             coagulation, fibrinolysis, or platelet function.

          -  Any clinically significant abnormal laboratory values.

          -  IgA deficiency.

          -  Seropositivity for hepatitis B surface antigen, hepatitis C virus, or human
             immunodeficiency virus type 1 or type 2 antibodies.

          -  Symptoms of a clinically relevant illness within 3 weeks before the first trial day.

          -  History of or suspected drug or alcohol abuse.

          -  Subjects currently participating in another clinical study.

          -  Any investigational medicinal product administration within the last 4 weeks.