Octaplas Pediatric Plasma Exchange Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adverse Effects in the Therapeutic Use of Plasma Substitutes

Intervention / Treatment
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* Biological: Octaplas™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pediatric patients undergoing TPE<br>octaplas™ | Biological: Octaplas™<br>* octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg.<br>* Other names: octaplas;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 8 days including the 24 hour follow-up from treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | up to 8 days including the 24 hour follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Octaplas