Safety/efficacy/tolerability of plasma products Injury, Occupational Diseases, Poisoning Complications following infusion, transfusion and therapeutic injection
Conditions
Interventions
The treatment day will start with plasmapheresis (600 ml) then transfusion of either OctaplasLG™ or Octaplas® SD will be randomly assigned. Safety, efficacy and tolerability will be assessed by clinic
Sponsors
Octapharma AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be capable of understanding and complying with all aspects of the protocol 2. Signed informed consent 3. Subject must be capable of understanding the plasmapheresis information sheet and sign it 4. Healthy male or female volunteers, aged 18 years or above 5. Women must have a negative pregnancy test (human chorionic gonadotrophin [HCG]-based assay) 6. Women must have sufficient methods of contraception (e.g. intrauterine device, oral contraception, etc.) 7. Subjects must have no clinically relevant abnormalities in medical history and general physical examination 8. Standard health insurance
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Tattoos within the last 3 months 3. Subject was treated therapeutically with FFP, blood or plasma derived products in the previous 6 months 4. Subjects have a hypersensitivity to blood products or plasma protein 5. History of angioedema 6. History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis or platelet function 7. Any clinically significant abnormal laboratory values 8. IgA deficiency 9. Seropositivity for HBs-Ag, HCV, HIV-1/2 antibodies 10. Symptoms of a clinically relevant illness within 3 weeks before the first trial day 11. Subjects with a history of, or suspected, drug or alcohol abuse 12. Subjects currently participating in another clinical study 13. Any IMP administration within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Coagulation factors 2. Activated partial thromboplastin time (aPTT), prothrombin time (PT), protein C All primary and secondary endpoints will be measured before and immediately after PP and at 15 minutes, 2 hours and 24 hours post-transfusion of IMP. Haematology and clinical chemistry will be measured 7 days after end of IMP administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Haematology: red blood cell (RBC) count, white blood cell (WBC) count, platelets, haematocrit (Hct), haemoglobin (Hb), and plasmin inhibitor, Protein S 2. Clinical Chemistry: electrolytes, creatinine, alanine aminotransferase (ALAT), gamma-glutamyl transferase (GGT), total protein (TP) 3. Overall tolerability, vital parameters All primary and secondary endpoints will be measured before and immediately after PP and at 15 minutes, 2 hours and 24 hours post-transfusion of IMP. Haematology and clinical chemistry will be measured 7 days after end of IMP administration. | — |
Countries
Austria
Outcome results
None listed