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Octaplas Pediatric Plasma Exchange Trial (Octaplas)

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ClinicalTrials.gov Identifier: NCT01938378
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : January 14, 2019
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.

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)
Estimated Enrollment : 40 participants
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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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. Primary objective is to assess safety and tolerability of octaplas™ in the pediatric population by monitoring ADRs, TEs, TEEs, and by measuring safety laboratory parameters. [ Time Frame: up to 8 days including the 24 hour follow-up from treatment ]
    Primary Endpoint is the monitoring of adverse drug reactions, TEs and TEEs caused by the octaplas™used for plasma exchange.


Secondary Outcome Measures :
  1. Assessment of safety laboratory parameters and investigator's assessment of overall safety. [ Time Frame: up to 8 days including the 24 hour follow-up ]


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 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
  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


Contacts
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Contact: Mikaela Grupp 866-337-1868 ctgov@clinicalresearchmgt.com

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

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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01938378     History of Changes
Other Study ID Numbers: LAS-213
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

Keywords provided by Octapharma:
Octaplas