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NCT00908037 · OUTCOME

Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1.

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
From Day 1 of treatment up to Week 24 of Part 1

What was measured

The percentage of participants achieving platelet counts \>=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment were reported.

Analysis population: ITT Population only those participants enrolled during Part 1 were analyzed.

Groups in this outcome

Part 1 (Dose-Finding Period) Cohort 1

Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

Part 1 (Dose-Finding Period) Cohort 2

Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of \<27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of \>=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

Part 1 (Dose-Finding Period) Cohort 3

Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study 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
Part 1 (Dose-Finding Period) Cohort 15
Part 1 (Dose-Finding Period) Cohort 25
Part 1 (Dose-Finding Period) Cohort 35

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 (Dose-Finding Period) Cohort 180Not reportedNot reportedNot reportedNot reported
Part 1 (Dose-Finding Period) Cohort 280Not reportedNot reportedNot reportedNot reported
Part 1 (Dose-Finding Period) Cohort 360Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        80
      3. group Id
        OG002
        value
        60
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      5
    units
    Participants
description
The percentage of participants achieving platelet counts \>=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment were reported.
groups
  1. description
    Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG000
    title
    Part 1 (Dose-Finding Period) Cohort 1
  2. description
    Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of \<27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of \>=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG001
    title
    Part 1 (Dose-Finding Period) Cohort 2
  3. description
    Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG002
    title
    Part 1 (Dose-Finding Period) Cohort 3
param Type
NUMBER
population Description
ITT Population only those participants enrolled during Part 1 were analyzed.
reporting Status
POSTED
time Frame
From Day 1 of treatment up to Week 24 of Part 1
title
Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1.
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice