Safety/tolerability (haemolytic transfusion reaction) after transfusion of Uniplas™ LG Not Applicable
Conditions
Interventions
The treatment day will start with plasmapheresis (600 ml) then transfusion of either Uniplas™ LG or Octaplas™ LG will be randomly assigned. Safety and tolerability will be assessed by clinical and lab
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. Fulfil criteria of plasma donors according to a standard questionnaire for blood components donors of the Department of Blood Group Serology and Transfusion Medicine 4. Healthy male or female volunteers greater than or equal to 18 years of age 5. Blood group A, B or AB 6. Women must have a negative pregnancy test (human chorionic gonadotropin [HCG]-based assay) 7. Women must have sufficient methods of contraception (e.g. intrauterine device, oral contraception) 8. Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant 9. Standard health insurance
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Refusal to accept blood products 3. Tattoos within the last 3 months 4. Treatment with fresh frozen plasma (FFP) or blood products in the previous 6 months 5. Subjects with a history of hypersensitivity reaction in general or hypersensitivity to blood products or plasma protein in particular 6. History of angioedema 7. History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis or platelet function 8. Any other clinically relevant history of disease 9. Any clinically significant abnormal laboratory values including Immmunoglobulin A (IgA) deficiency 10. Seropositivity for hepatitis B surface antigens (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus 1/2 (HIV-1/2) antibodies 11. Symptoms of a clinically relevant illness within 3 weeks before the first trial day 12. Subjects with a history of, or suspected, drug or alcohol abuse 13. Subjects participating in another clinical study currently or during the past 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Haemoglobin (Hb), measured before and immediately after PP and at 15 minutes, 2 hours, 24 hours, 7 days and 3 months after end of IMP administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parameters of haemolysis (haptoglobin, free Hb, indirect bilirubin) 2. Complement activation (CH50, C3c, C4) 3. Immune haematology (direct antiglobulin test [DAT]) 4. Haematology (red blood cell [RBC] count, white blood cell [WBC] count, platelets, haematocrit [Hct]) 5. Haemostatic parameters (activated partial thromboplastin time [aPTT], prothrombin time [PT], fibrinogen [Fbg], factor II [FII], factor V [FV], factor VII [FVII], factor VIII [FVIII], factor IX [FIX], factor X [FX], factor XI [FXI], protein S, plasmin inhibitor) 6. Changes in viral status over the study period (anti-HIV-1/2, HBsAg, hepatitis B core antigen [anti-HBc], anti-HCV, cytomegalovirus antigen [anti-CMV], hepatitis A virus antibody [anti-HAV], anti-Parvovirus B19) 7. Overall tolerability, vital parameters including body temperature, standard safety laboratory parameters All primary and secondary endpoints will be measured before and immediately after PP and at 15 minutes/2 hours post-transfusion of IMP. The following extra timepoints will also be used: 1. 24 hours after end of IMP administration: haematology, DAT, complement and coagulation factors 2. 7 days after end of IMP administration: haematology, DAT and complement 3. 3 months after end of IMP administration: haematology, DAT, aPTT, PT, Fbg, and viral markers | — |
Countries
Austria
Outcome results
None listed