A comparative, open-label, randomised, cross-over phase I trial in healthy volunteers to investigate the relative efficacy, safety and tolerability of OctaplasLG™ versus Octaplas® SD
- Conditions
- Safety/efficacy/tolerability of plasma productsInjury, Occupational Diseases, PoisoningComplications following infusion, transfusion and therapeutic injection
- Registration Number
- ISRCTN35401703
- Lead Sponsor
- Octapharma AG (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Coagulation factors<br>2. Activated partial thromboplastin time (aPTT), prothrombin time (PT), protein C<br><br>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 Outcome Measures
Name Time Method 1. Haematology: red blood cell (RBC) count, white blood cell (WBC) count, platelets, haematocrit (Hct), haemoglobin (Hb), and plasmin inhibitor, Protein S<br>2. Clinical Chemistry: electrolytes, creatinine, alanine aminotransferase (ALAT), gamma-glutamyl transferase (GGT), total protein (TP)<br>3. Overall tolerability, vital parameters<br><br>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.