NCT01938378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 24, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

3.8 years

First QC Date

September 2, 2013

Results QC Date

February 25, 2020

Last Update Submit

March 23, 2020

Conditions

Adverse Effects in the Therapeutic Use of Plasma Substitutes

Keywords

Octaplas

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (17)

  • Assessment of Blood Urea Nitrogen Levels

    up to 8 days including the 24 hour follow-up

  • Assessment of Carbon Dioxide Levels

    up to 8 days including the 24 hour follow-up

  • Assessment of Chloride Levels

    up to 8 days including the 24 hour follow-up

  • Assessment of Creatinine Levels

    up to 8 days including the 24 hour follow-up

  • Assessment of Glucose Levels

    up to 8 days including the 24 hour follow-up

  • +12 more secondary outcomes

Study Arms (1)

Pediatric patients undergoing TPE

OTHER

octaplas™

Biological: Octaplas™

Interventions

Octaplas™BIOLOGICAL

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

Also known as: octaplas
Pediatric patients undergoing TPE

Eligibility Criteria

Age2 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients in whom therapeutic plasma exchange (TPE) is required.
  • Patient is male or female ≥ 2 years to ≤ 20 years of age.
  • 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.

You may not qualify if:

  • Patient with known homozygous congenital deficiency of Protein S.
  • Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product.
  • Patient has an already known IgA deficiency with documented antibodies against IgA.
  • Patient is pregnant.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Octapharma Research Site

Birmingham, Alabama, 35233, United States

Location

Octapharma Research Site

Atlanta, Georgia, 30322, United States

Location

Octapharma Research Site

New Orleans, Louisiana, 70118, United States

Location

Octapharma Research Site

Minneapolis, Minnesota, 55455, United States

Location

Octapharma Research Site

Kansas City, Missouri, 64108, United States

Location

Octapharma Research Site

St Louis, Missouri, 63130, United States

Location

Octapharma Research Site

Durham, North Carolina, 27710, United States

Location

Octapharma Research Site

Cincinnati, Ohio, 45229, United States

Location

Results Point of Contact

Title
Michael Eppolito
Organization
Octapharma
michael.eppolito@octapharma.com
201-604-1155

Study Officials

  • Wolfgang Frenzel, MD

    Medical Director

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 10, 2013

Study Start

April 1, 2015

Primary Completion

January 27, 2019

Study Completion

January 27, 2019

Last Updated

March 24, 2020

Results First Posted

March 24, 2020

Record last verified: 2020-03

Locations

US(8)