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Completed

NCT Number: NCT01938378

Octaplas Pediatric Plasma Exchange Trial

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.

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Key information

Conditions

Adverse Effects in the Therapeutic Use of Plasma Substitutes

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Octapharma Research Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Octaplas™

Biological

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

Other names: octaplas

Primary outcomes

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

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

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

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

Secondary outcomes

  1. Assessment of Blood Urea Nitrogen Levels

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

    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.

  2. Assessment of Carbon Dioxide Levels

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

    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.

  3. Assessment of Chloride Levels

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

    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.

  4. Assessment of Creatinine Levels

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

    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.

  5. Assessment of Glucose Levels

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

    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.

  6. Assessment of Potassium Levels

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

    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.

  7. Assessment of Sodium Levels

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

    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.

  8. Assessment of Leukocyte Levels

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

    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.

  9. Assessment of Erythrocyte Levels

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

    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.

  10. Assessment of Hemoglobin Levels

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

    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.

  11. Assessment of Hematocrit Levels

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

    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.

  12. Assessment of Mean Corpuscular Volume Levels

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

    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.

  13. Assessment of Mean Corpuscular Hemoglobin Levels

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

    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.

  14. Assessment of Mean Corpuscular Hemoglobin Concentration Levels

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

    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.

  15. Assessment of Mean Red Cell Distribution Width Levels

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

    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.

  16. Assessment of Mean Ionized Calcium Levels

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

    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.

  17. Investigator's Assessment of Overall Safety

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

    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

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study 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

Acronym: Octaplas

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2013
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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