Octaplas Pediatric Plasma Exchange Trial

Phase 4CompletedNCT01938378

Octapharma41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adverse Effects in the Therapeutic Use of Plasma Substitutes

Interventions

Octaplas™BIOLOGICAL

octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 20 Years

Medical Language ↔ Plain English

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.

Locations (8)

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

Outcomes

Primary Outcomes

Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.

Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange.

Time frame: up to 8 days including the 24 hour follow-up from treatment

Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange.

Monitoring of Thrombotic Events (TEs) and Thromboembolic Events (TEEs) caused by the octaplas™used for plasma exchange.

Time frame: up to 8 days including the 24 hour follow-up from treatment

Secondary Outcomes

Assessment of Blood Urea Nitrogen Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Carbon Dioxide Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Chloride Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Creatinine Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Data from ClinicalTrials.gov

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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

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Glucose Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Potassium Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Sodium Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Leukocyte Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Erythrocyte Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Hemoglobin Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Hematocrit Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Mean Corpuscular Volume Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Mean Corpuscular Hemoglobin Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Mean Corpuscular Hemoglobin Concentration Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Mean Red Cell Distribution Width Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Assessment of Mean Ionized Calcium Levels

Blood samples compare levels before each TPE (therapeutic plasma exchange), during each TPE, and after each TPE. Pre-TPE is within 24 hours before TPE start; Follow-Up is 24 (+/-2) hours after TPE end.

Time frame: up to 8 days including the 24 hour follow-up

Investigator's Assessment of Overall Safety

Excellent: defined as the treatment was well tolerated by the patient; Moderate: defined as Adverse Drug Reaction (ADR(s)) were observed, but easily resolved or not clinically significant; Poor: defined as ADR(s) were observed requiring significant medical intervention

Time frame: up to 8 days including the 24 hour follow-up