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NCT01520909 · OUTCOME

Pharmacokinetic (PK) Assessments for Eltrombopag for AUC (0-t)

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
micrograms*hour per milliliter (ug.h/mL)
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. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. The AUC(0-t) for a 50mg dose was estimated for each cohort. 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 for a 50mg dose.

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

Source class 1
Values in micrograms*hour per milliliter (ug.h/mL) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Eltrombopag Cohort 1 (12-17 Years)104Not reported86.1126Not reported
Eltrombopag Cohort 2 (6-11 Years)171Not reported147200Not reported
Eltrombopag Cohort 3 (1-5 Years)184Not reported147230Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        86.1
        upper Limit
        126
        value
        104
      2. group Id
        OG001
        lower Limit
        147
        upper Limit
        200
        value
        171
      3. group Id
        OG002
        lower Limit
        147
        upper Limit
        230
        value
        184
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. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. The AUC(0-t) for a 50mg dose was estimated for each cohort. 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 for a 50mg dose.
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 AUC (0-t)
type
SECONDARY
unit Of Measure
micrograms*hour per milliliter (ug.h/mL)

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Preserved source evidence · Not medical advice