Astudy to investigate the safety and tolerability of octaplas™ in the management of pediatric patients who require therapeutic plasma exchange.

Phase 1

• Conditions: Therapeutic plasma exchange; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2020-000650-10-Outside-EU/EEA
• Lead Sponsor: Octapharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-01-27
• Study Start: 2020-02-12
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 41

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Patient with known homozygous congenital deficiency of Protein S.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess the safety and tolerability of octaplas™ in the pediatric population by monitoring ADRs, TEs, TEEs, and by measuring safety laboratory parameters.;Secondary Objective: Not applicable;Primary end point(s): Monitoring of serious adverse events (SAEs), adverse drug reactions, TEs, and TEEs caused by the octaplas™ used for plasma exchange.;Timepoint(s) of evaluation of this end point: Up to 8 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Safety laboratory parameters (Complete Blood Count (CBC), the ‘Chem 7’ lab panel (Chem 7), and ionized calcium).<br>• Investigator’s assessment of overall safety.;Timepoint(s) of evaluation of this end point: Up to 8 days