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Octaplas Pediatric Plasma Exchange Trial (Octaplas)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01938378
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Octapharma

Brief 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.

Condition or disease Intervention/treatment Phase
Adverse Effects in the Therapeutic Use of Plasma Substitutes Biological: Octaplas™ Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : January 27, 2019
Actual Study Completion Date : January 27, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Octaplas

Arm Intervention/treatment
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 Name: octaplas




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938378


Locations
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United States, Alabama
Octapharma Research Site
Birmingham, Alabama, United States, 35233
United States, Georgia
Octapharma Research Site
Atlanta, Georgia, United States, 30322
United States, Louisiana
Octapharma Research Site
New Orleans, Louisiana, United States, 70118
United States, Minnesota
Octapharma Research Site
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Octapharma Research Site
Kansas City, Missouri, United States, 64108
Octapharma Research Site
Saint Louis, Missouri, United States, 63130
United States, North Carolina
Octapharma Research Site
Durham, North Carolina, United States, 27710
United States, Ohio
Octapharma Research Site
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Octapharma
Investigators
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Study Director: Wolfgang Frenzel, MD Medical Director
  Study Documents (Full-Text)

Documents provided by Octapharma:
Study Protocol  [PDF] October 19, 2018
Statistical Analysis Plan  [PDF] November 22, 2018

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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01938378    
Other Study ID Numbers: LAS-213
First Posted: September 10, 2013    Key Record Dates
Results First Posted: March 24, 2020
Last Update Posted: March 24, 2020
Last Verified: March 2020
Keywords provided by Octapharma:
Octaplas