Octaplas Pediatric Plasma Exchange Trial (Octaplas)

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 in pediatric patients who require therapeutic plasma exchange.

Study Overview

• Status: Completed
• Conditions: Adverse Effects in the Therapeutic Use of Plasma Substitutes
• Intervention / Treatment: Biological: Octaplas™

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Octapharma Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Octapharma Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Octapharma Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Octapharma Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Octapharma Research Site
    • Saint Louis, Missouri, United States, 63130
      • Octapharma Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Octapharma Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Octapharma Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Octapharma
• Investigators: Study Director: Wolfgang Frenzel, MD, Medical Director

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): January 27, 2019
• Study Completion (ACTUAL): January 27, 2019

Study Registration Dates

• First Submitted: September 2, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (ESTIMATE): September 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Octaplas
• Other Study ID Numbers: LAS-213