Clinical trial NCT01938378: Octaplas Pediatric Plasma Exchange Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Effects in the Therapeutic Use of Plasma Substitutes
Keywords: Octaplas
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2013-09-10
Enrollment: 41
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients in whom therapeutic plasma exchange (TPE) 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. Concurrent participation in a device study will be considered on a case by case basis.
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.

Primary outcomes:
measure: Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.
timeFrame: up to 8 days including the 24 hour follow-up from treatment
measure: Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange.
timeFrame: up to 8 days including the 24 hour follow-up from treatment
Secondary outcomes:
measure: Assessment of Blood Urea Nitrogen Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Carbon Dioxide Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Chloride Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Creatinine Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Glucose Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Potassium Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Sodium Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Leukocyte Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Erythrocyte Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Hemoglobin Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Hematocrit Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Mean Corpuscular Volume Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Mean Corpuscular Hemoglobin Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Mean Corpuscular Hemoglobin Concentration Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Mean Red Cell Distribution Width Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Assessment of Mean Ionized Calcium Levels
timeFrame: up to 8 days including the 24 hour follow-up
measure: Investigator's Assessment of Overall Safety
timeFrame: up to 8 days including the 24 hour follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Octapharma Research Site
state: Alabama
city: Atlanta
country: United States
facility: Octapharma Research Site
state: Georgia
city: New Orleans
country: United States
facility: Octapharma Research Site
state: Louisiana
city: Minneapolis
country: United States
facility: Octapharma Research Site
state: Minnesota
city: Kansas City
country: United States
facility: Octapharma Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Octapharma Research Site
state: Missouri
city: Durham
country: United States
facility: Octapharma Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Octapharma Research Site
state: Ohio
Study officials:
affiliation: Medical Director
name: Wolfgang Frenzel, MD
role: STUDY_DIRECTOR
References: