Clinical Trial Results:
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.
Summary
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EudraCT number |
2020-000650-10 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
27 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Mar 2020
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First version publication date |
12 Mar 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
LAS-213
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01938378 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Octapharma
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Sponsor organisation address |
121 River Street, Hoboken, United States, 07030
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Public contact |
Michael Eppolito, Octapharma, michael.eppolito@octapharma.com
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Scientific contact |
Michael Eppolito, Octapharma, michael.eppolito@octapharma.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Jan 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Jan 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Jan 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective is to assess the safety and tolerability of octaplas™ in the pediatric patients undergoing therapeutic plasma exchange (TPE) by monitoring ADRs, TEs, TEEs, and by measuring safety laboratory parameters.
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Protection of trial subjects |
This trial was conducted in accordance to the principles of GCP, ensuring that the rights, safety and well-being of patients are protected and in consistency with the Declaration of Helsinki. Inclusion and exclusion criteria were carefully defined in order to protect subjects from contraindications, interactions with other medication and risk factors associated with the investigational medicinal product. Throughout the study safety was assessed, such as occurrence of SAEs, ADRs, TEs, TEEs, and safety labs.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Apr 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 41
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Worldwide total number of subjects |
41
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
15
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Adolescents (12-17 years) |
17
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Adults (18-64 years) |
9
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
Male or female patients aged 2 years through 20 years of age requiring therapeutic plasma exchange. | ||||||
Period 1
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Period 1 title |
Overall Trial (Overall Period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Octaplas | ||||||
Arm description |
Therapeutic plasma exchange with Octaplas | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Octaplas
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
The recommended dose is a total plasma volume between 40 to 60 mL/kg, as prescribed by the treating physician.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial (Overall Period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Age Group 1 (2-<12)
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Ages 2 to <12
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Subject analysis set title |
Age Group 2 (12-<17)
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Ages 12 to <17
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Subject analysis set title |
Age Group 3 (≥17)
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Ages ≥17
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End points reporting groups
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Reporting group title |
Octaplas
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Reporting group description |
Therapeutic plasma exchange with Octaplas | ||
Subject analysis set title |
Age Group 1 (2-<12)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Ages 2 to <12
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Subject analysis set title |
Age Group 2 (12-<17)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Ages 12 to <17
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Subject analysis set title |
Age Group 3 (≥17)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Ages ≥17
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End point title |
Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange. [1] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
up to 8 days including the 24 hour follow-up from treatment
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Count of Adverse Drug Reactions |
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No statistical analyses for this end point |
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End point title |
Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange. [2] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
up to 8 days including the 24 hour follow-up from treatment
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Count of TEs and TEEs |
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No statistical analyses for this end point |
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End point title |
Assessment of Blood Urea Nitrogen Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [3] - TPE 1 34 subj. TPE 2 17 subj. TPE 3 11 subj. TPE 4 8 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Carbon Dioxide Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [4] - TPE 1 34 subj. TPE 2 17 subj. TPE 3 11 subj. TPE 4 8 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Chloride Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [5] - TPE 1 34 subj. TPE 2 17 subj. TPE 3 11 subj. TPE 4 8 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Creatinine Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [6] - TPE 1 34 subj. TPE 2 17 subj. TPE 3 11 subj. TPE 4 8 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Glucose Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [7] - TPE 1 34 subj. TPE 2 17 subj. TPE 3 11 subj. TPE 4 8 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Potassium Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [8] - TPE 1 34 subj. TPE 2 17 subj. TPE 3 11 subj. TPE 4 8 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Sodium Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [9] - TPE 1 34 subj. TPE 2 17 subj. TPE 3 11 subj. TPE 4 8 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Leukocyte Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [10] - TPE 1 34 subj. TPE 2 18 subj. TPE 3 9 subj. TPE 4 7 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Erythrocyte Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [11] - TPE 1 34 subj. TPE 2 18 subj. TPE 3 9 subj. TPE 4 7 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Hemoglobin Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [12] - TPE 1 34 subj. TPE 2 18 subj. TPE 3 9 subj. TPE 4 7 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Hematocrit Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [13] - TPE 1 34 subj. TPE 2 18 subj. TPE 3 9 subj. TPE 4 7 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Mean Corpuscular Volume Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [14] - TPE 1 34 subj. TPE 2 18 subj. TPE 3 9 subj. TPE 4 7 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Mean Corpuscular Hemoglobin Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [15] - TPE 1 34 subj. TPE 2 18 subj. TPE 3 9 subj. TPE 4 7 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Mean Corpuscular Hemoglobin Concentration Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [16] - TPE 1 34 subj. TPE 2 18 subj. TPE 3 9 subj. TPE 4 7 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Mean Red Cell Distribution Width Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [17] - TPE 1 34 subj. TPE 2 18 subj. TPE 3 9 subj. TPE 4 7 subj. TPE 5 4 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Assessment of Mean Ionized Calcium Levels from Pre-TPE to Post-TPE | ||||||||||||||||||||
End point description |
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. Differences in number of subjects analyzed for each TPE due to not all patients receiving multiple blood draws/TPEs.
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [18] - TPE 1 28 subj. TPE 2 14 subj. TPE 3 12 subj. TPE 4 8 subj. TPE 5 6 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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End point title |
Investigator's Assessment of Overall Safety | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Excellent: defined as the treatment was well tolerated by the patient; Moderate: defined as ADR(s) were observed, but easily resolved or not clinically significant; Poor: defined as ADR(s) were observed requiring significant medical intervention
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End point type |
Secondary
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End point timeframe |
up to 8 days including the 24 hour follow-up
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Notes [19] - TPE 1 41 subj. TPE 2 26 subj. TPE 3 18 subj. TPE 4 10 subj. TPE 5 6 subj. TPE 6 1 subj. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to 8 Days
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Adverse event reporting additional description |
ADRs will be elicited using a standard non-leading question such as “How have you been since the last evaluation?” If children or adolescent patients are unable to adequately understand and respond to this question, the information will be obtained from the patient’s guardian and/or Investigator or study nurse.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18
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Reporting groups
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Reporting group title |
Octaplas
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Reporting group description |
Therapeutic plasma exchange with Octaplas | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pediatric Patients Undergoing TPE Age Group 1
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Reporting group description |
Age Group 1 (2-<12) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pediatric Patients Undergoing TPE Age Group 2
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Reporting group description |
Age Group 2 (12-<17) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pediatric Patients Undergoing TPE Age Group 3
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Reporting group description |
Age Group 3 (≥17) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |