An open label phase I study in healthy subjects with blood group AB to investigate the safety, tolerability and efficacy of Uniplas™ LG

Completed

• Conditions: Transfusion; Substitution of intentionally removed plasma; Signs and Symptoms

• Registration Number: ISRCTN45060587
• Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified