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NCT00908037 · OUTCOME

Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3

Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) · Source last updated 2018-10-12

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

Measure
MEDIAN
Unit
hour (hr)
Interval / dispersion
Full Range
Time frame
From Day 1 of treatment up to Study Week 31

What was measured

The time to maximum concentration (tmax) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of tmax was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.

Analysis population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.

Groups in this outcome

Eltrombopag Cohort 1- 12-17 Years

Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.

Eltrombopag Cohort 2 - 6-11 Years

Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing \<27 kilograms (kg) started at 12.5mg QD and par weighing \>=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing \<27kg started at 25mg QD and par weighing \>=27kg started at 50mg QD. Par of East Asian ancestry weighing \<27kg began at 12.5mg QD and those \>=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.

Eltrombopag Cohort 3 - 1-5 Years

Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.

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 Years29
Eltrombopag Cohort 2 - 6-11 Years30
Eltrombopag Cohort 3 - 1-5 Years19

Reported measurements

Source class 1
Values in hour (hr) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Eltrombopag Cohort 1- 12-17 Years4.0Not reported2.06.0Not reported
Eltrombopag Cohort 2 - 6-11 Years4.0Not reported2.06.0Not reported
Eltrombopag Cohort 3 - 1-5 Years2.0Not reported2.04.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        6.0
        value
        4.0
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        6.0
        value
        4.0
      3. group Id
        OG002
        lower Limit
        2.0
        upper Limit
        4.0
        value
        2.0
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      19
    units
    Participants
description
The time to maximum concentration (tmax) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of tmax was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.
dispersion Type
Full Range
groups
  1. description
    Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
    id
    OG000
    title
    Eltrombopag Cohort 1- 12-17 Years
  2. description
    Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing \<27 kilograms (kg) started at 12.5mg QD and par weighing \>=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing \<27kg started at 25mg QD and par weighing \>=27kg started at 50mg QD. Par of East Asian ancestry weighing \<27kg began at 12.5mg QD and those \>=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
    id
    OG001
    title
    Eltrombopag Cohort 2 - 6-11 Years
  3. description
    Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
    id
    OG002
    title
    Eltrombopag Cohort 3 - 1-5 Years
param Type
MEDIAN
population Description
Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.
reporting Status
POSTED
time Frame
From Day 1 of treatment up to Study Week 31
title
Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3
type
SECONDARY
unit Of Measure
hour (hr)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice