Substitution of intentionally removed plasma Signs and Symptoms Transfusion
Conditions
Interventions
Primary objective of this study is to investigate the safety and the tolerability of Uniplas™ LG, assessed by clinical and laboratory parameters with respect to subjects with blood group AB. IMP will
Sponsors
Octapharma AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent 2. Subject must be capable to understand and comply with all relevant aspects of the study protocol 3. Blood group AB 4. Healthy male or female subjects greater than or equal to 18 years of age 5. Female subject must have a negative pregnancy test (human chorionic gonadotropin [HCG]-based assay) 6. Female subject must apply sufficient methods of contraception 7. Subject must have no clinically relevant abnormalities in medical history and general physical examination 8. A standard health insurance must be in place for the subject
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Subject got tattoos within the last 3 months 3. Subject was treated therapeutically with FFP, blood or plasma-derived products in the previous 6 months 4. Angiotensin converting enzyme (ACE)-inhibitors 5. Subject has a history of severe hypersensitivity to blood products or plasma protein 6. History of angiooedema 7. History of coagulation disorder or bleeding disorder and any known abnormality affecting coagulation, fibrinolysis or platelet function 8. Any other clinically relevant history of disease 9. Subject has clinically significant abnormal laboratory values 10. Subject has IgA deficiency 11. Seropositivity for hepatitis B surface antigens (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus (HIV-1/2) antibodies 12. Symptoms of a clinically relevant illness within 3 weeks before Visit 2 13. Subject has a history of or a suspected drug or alcohol abuse 14. Participation in another clinical study within the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Haemoglobin (Hb), measured at baseline, less than or equal to 30 minutes before and less than 5 minutes post plasmapheresis, 15 minutes and 2 hours post-transfusion, 24 hours and 7 days post-plasmapherese and 3 months after administration of IMP. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parameters of haemolysis: haptoglobin, free Hb, indirect bilirubin 2. Complement activation: CH50, C3c, C4 3. Circulating immune complexes (CIC): IgG, IgA, IgM 4. DAT (direct antiglobulin test) 5. Isoagglutinines (in case of a positive DAT) 6. Haematology: RBC count, WBC count, platelets, Hct, Hb 7. Standard safety lab (Clinical chemistry): sodium (Na+), potassium (K+), calcium (Ca2+), creatinine, ALAT, gamma-glutamyl transferase (gGT), total protein (TP) 8. Haemostatic Panel I: aPTT, PT, Fbg 9. Haemostatic Panel II: FII, FV, FVII, FVIII, FIX, FX, FXI, Protein C, Protein S, plasmin inhibitor) 10. Urine analysis: WBC, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/Hb 11. Changes in viral status over the study period: anti-HIV-1/2, HBsAg, anti-HBc, anti-HCV, anti-CMV, anti-HAV, anti-Parvovirus B19 12. Overall tolerability, AE monitoring, vital signs including body temperature Measured at baseline, less than or equal to 30 minutes before and less than 5 minutes post plasmapheresis, 15 minutes and 2 hours post-transfusion, 24 hours and 7 days post-plasmapherese and 3 months after administration of IMP. | — |
Countries
Austria
Outcome results
None listed