Octaplas Pediatric Plasma Exchange Trial



Status:Recruiting
Healthy:No
Age Range:2 - 20
Updated:1/16/2019
Start Date:April 2015
End Date:December 2020
Contact:Mikaela Grupp
Email:ctgov@clinicalresearchmgt.com
Phone:866-337-1868

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An Open-label, Multicenter, Post-Marketing Requirement Study to Investigate the Safety and Tolerability of Octaplas™ in the Management of Pediatric Patients Who Require Therapeutic Plasma Exchange

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.


Inclusion Criteria:

1. Patients in whom therapeutic plasma exchange is required.

2. Patient is male or female ≥ 2 years to ≤ 20 years of age.

3. 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.

Exclusion Criteria:

1. Patient with known homozygous congenital deficiency of Protein S.

Exclusion Criteria:

2. Patient has a history of severe hypersensitivity reaction to plasma-derived products
or to any excipient of the investigational product.

3. Patient has an already known IgA deficiency with documented antibodies against IgA.

4. 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

5. Patient is pregnant.

6. 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.
We found this trial at
8
sites
Durham, North Carolina 27710
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Atlanta, Georgia 30322
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Atlanta, GA
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Birmingham, Alabama 35233
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Birmingham, AL
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Kansas City, Missouri 64108
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Minneapolis, Minnesota 55455
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Minneapolis, MN
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New Orleans, Louisiana 70118
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New Orleans, LA
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8780 Pershall Road
Saint Louis, Missouri 63130
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Saint Louis, MO
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