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NCT01520909 · OUTCOME

Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Oral Clearance (CL/F) and Apparent Intercompartmental Clearance (Q/F)

Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. · Source last updated 2015-03-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
Liters per hour (L/hr)
Interval / dispersion
95% Confidence Interval
Time frame
Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)

What was measured

Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.

Analysis population: PK Population. Only those participants who provided pharmacokinetic samples were analyzed

Groups in this outcome

Eltrombopag Cohort 1 (12-17 Years)

Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.

Eltrombopag Cohort 2 (6-11 Years)

Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.

Eltrombopag Cohort 3 (1-5 Years)

Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Eltrombopag Cohort 1 (12-17 Years)33
Eltrombopag Cohort 2 (6-11 Years)38
Eltrombopag Cohort 3 (1-5 Years)19

Reported measurements

CL/F
Values in Liters per hour (L/hr) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Eltrombopag Cohort 1 (12-17 Years)0.48Not reported0.400.58Not reported
Eltrombopag Cohort 2 (6-11 Years)0.29Not reported0.250.34Not reported
Eltrombopag Cohort 3 (1-5 Years)0.19Not reported0.150.24Not reported
Q/F
Values in Liters per hour (L/hr) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Eltrombopag Cohort 1 (12-17 Years)0.61Not reported0.540.68Not reported
Eltrombopag Cohort 2 (6-11 Years)0.38Not reported0.340.42Not reported
Eltrombopag Cohort 3 (1-5 Years)0.24Not reported0.200.28Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.40
        upper Limit
        0.58
        value
        0.48
      2. group Id
        OG001
        lower Limit
        0.25
        upper Limit
        0.34
        value
        0.29
      3. group Id
        OG002
        lower Limit
        0.15
        upper Limit
        0.24
        value
        0.19
    title
    CL/F
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.54
        upper Limit
        0.68
        value
        0.61
      2. group Id
        OG001
        lower Limit
        0.34
        upper Limit
        0.42
        value
        0.38
      3. group Id
        OG002
        lower Limit
        0.20
        upper Limit
        0.28
        value
        0.24
    title
    Q/F
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      38
    3. group Id
      OG002
      value
      19
    units
    Participants
description
Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
    id
    OG000
    title
    Eltrombopag Cohort 1 (12-17 Years)
  2. description
    Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
    id
    OG001
    title
    Eltrombopag Cohort 2 (6-11 Years)
  3. description
    Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
    id
    OG002
    title
    Eltrombopag Cohort 3 (1-5 Years)
param Type
GEOMETRIC_MEAN
population Description
PK Population. Only those participants who provided pharmacokinetic samples were analyzed
reporting Status
POSTED
time Frame
Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)
title
Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Oral Clearance (CL/F) and Apparent Intercompartmental Clearance (Q/F)
type
SECONDARY
unit Of Measure
Liters per hour (L/hr)

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Preserved source evidence · Not medical advice