Octaplas Pediatric Plasma Exchange Trial

Adverse Effects in the Therapeutic Use of Plasma Substitutes Clinical Trial

— Octaplas  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938378
• Other study ID #: LAS-213
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: January 27, 2019

Study information

• Verified date: March 2020
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 27, 2019
• Est. primary completion date: January 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Effects in the Therapeutic Use of Plasma Substitutes

Intervention

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

Locations

Country	Name	City	State
United States	Octapharma Research Site	Atlanta	Georgia
United States	Octapharma Research Site	Birmingham	Alabama
United States	Octapharma Research Site	Cincinnati	Ohio
United States	Octapharma Research Site	Durham	North Carolina
United States	Octapharma Research Site	Kansas City	Missouri
United States	Octapharma Research Site	Minneapolis	Minnesota
United States	Octapharma Research Site	New Orleans	Louisiana
United States	Octapharma Research Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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