Octaplas Pediatric Plasma Exchange Trial

Completed · Phase 4

Conditions studied: Adverse Effects in the Therapeutic Use of Plasma Substitutes

In brief

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.

Key facts

Study ID

NCT01938378

Run by

Octapharma

People needed

41

Starts

2015-04-01

Expected to finish

2019-01-27

Last updated by the study team

2020-03-24

Who can join

Age: 2 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients in whom therapeutic plasma exchange (TPE) is required.
• Patient is male or female ≥ 2 years to ≤ 20 years of age.
• Patient or patient's legal representative(s)/guardian(s) has /have given voluntarily written and signed informed consent before any study-related procedure is to be performed. If children are old enough (age usually deemed by each institution) to understand the risks and benefits of the study, they should also be informed and provide their written assent.

You may not qualify if…

• 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.

Where it is running

• Octapharma Research Site — Birmingham, Alabama, United States
• Octapharma Research Site — Atlanta, Georgia, United States
• Octapharma Research Site — New Orleans, Louisiana, United States
• Octapharma Research Site — Minneapolis, Minnesota, United States
• Octapharma Research Site — Kansas City, Missouri, United States
• Octapharma Research Site — St Louis, Missouri, United States
• Octapharma Research Site — Durham, North Carolina, United States
• Octapharma Research Site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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