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About
To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric patients who require therapeutic plasma exchange.
Enrollment
Sex
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Inclusion criteria
Exclusion criteria
Patient with known homozygous congenital deficiency of Protein S.
Exclusion Criteria:
Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product.
Patient has an already known IgA deficiency with documented antibodies against IgA.
Patient is currently participating in another interventional clinical study or has participated during the past 1 month prior to study inclusion. This is not applicable to non-interventional trials and does not exclude patients who have been exposed to Investigational Medicinal Product with a washout of at least 30 days from enrollment in LAS-213. Concurrent participation in a device study will be considered on a case by case basis.
Patient is pregnant.
Use of Angiotensin-Converting-Enzyme-inhibitors within 72 hours of the start of the first infusion episode or planned used of these medications while on study.
Primary purpose
Allocation
Interventional model
Masking
41 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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