Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT01063595
Eligibility Criteria:
Inclusion Criteria:
* Capable of understanding and complying with all aspects of the protocol.
* Signed Informed Consent.
* Capable of understanding the plasmapheresis information sheet and sign it.
* Healthy male or female volunteers, age 18 years or older.
* Women must have negative pregnancy test (human chorionic gonadotropin \[HCG\] based assay).
* Women must have sufficient methods of contraception (eg, intrauterine device, oral contraception, etc).
* No clinically relevant abnormalities in medical history and general physical examination.
* Standard health insurance.
Exclusion Criteria:
* Pregnancy or lactation.
* Tattoos within the last 3 months.
* Subject was treated therapeutically with fresh frozen plasma, blood, or plasma-derived products within the last 6 months.
* Hypersensitivity to blood products or plasma proteins.
* History of angioedema.
* History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis, or platelet function.
* Any clinically significant abnormal laboratory values.
* IgA deficiency.
* Seropositivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus type 1 or type 2 antibodies.
* Symptoms of a clinically relevant illness within 3 weeks before the first trial day.
* History of or suspected drug or alcohol abuse.
* Subjects currently participating in another clinical study.
* Any investigational medicinal product administration within the last 4 weeks.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01063595
Study Brief:
Protocol Section:
NCT01063595