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Octaplas Pediatric Plasma Exchange Trial

NCT01938378 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-03-24

Study results available
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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.

Conditions

  • Adverse Effects in the Therapeutic Use of Plasma Substitutes

Interventions

BIOLOGICAL

Octaplas™

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

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Wolfgang Frenzel, MD · Medical Director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-01-27
Completion
2019-01-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01938378 on ClinicalTrials.gov