Octaplas Pediatric Plasma Exchange Trial

Octapharma

Status and phase

Completed

Phase 4

Conditions

Adverse Effects in the Therapeutic Use of Plasma Substitutes

Treatments

Biological: Octaplas™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01938378

LAS-213

Details and patient eligibility

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

41 patients

Sex

All

Ages

2 to 20 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

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.