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NCT00908037 · OUTCOME

Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2)

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 8 up to Day 43 of Part 2

What was measured

Participants who achieved a platelet count \>=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.

Analysis population: Intent-to-Treat (ITT) Population: all enrolled participants during Part 2. The ITT Population was the primary population used for assessing efficacy. Only evaluable participants were considered for analysis where participants with a Baseline platelet count \>10Gi/L was considered as evaluable.

Groups in this outcome

Part 2 (Randomized Period) Cohort 1-Placebo

Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.

Part 2 (Randomized Period) Cohort 1- Eltrombopag

Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

Part 2 (Randomized Period) Cohort 2-Placebo

Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.

Part 2 (Randomized Period) Cohort 2-Eltrombopag

Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

Part 2 (Randomized Period) Cohort 3-Placebo

Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.

Part 2 (Randomized Period) Cohort 3- Eltrombopag

Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, 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 2 (Randomized Period) Cohort 1-Placebo8
Part 2 (Randomized Period) Cohort 1- Eltrombopag16
Part 2 (Randomized Period) Cohort 2-Placebo9
Part 2 (Randomized Period) Cohort 2-Eltrombopag17
Part 2 (Randomized Period) Cohort 3-Placebo5
Part 2 (Randomized Period) Cohort 3- Eltrombopag10

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Randomized Period) Cohort 1-Placebo0Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag62.5Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 2-Placebo33.3Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag63.2Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 3-Placebo80.0Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag60.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        62.5
      3. group Id
        OG002
        value
        33.3
      4. group Id
        OG003
        value
        63.2
      5. group Id
        OG004
        value
        80.0
      6. group Id
        OG005
        value
        60.0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      17
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      10
    units
    Participants
description
Participants who achieved a platelet count \>=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.
groups
  1. description
    Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
    id
    OG000
    title
    Part 2 (Randomized Period) Cohort 1-Placebo
  2. description
    Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG001
    title
    Part 2 (Randomized Period) Cohort 1- Eltrombopag
  3. description
    Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
    id
    OG002
    title
    Part 2 (Randomized Period) Cohort 2-Placebo
  4. description
    Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG003
    title
    Part 2 (Randomized Period) Cohort 2-Eltrombopag
  5. description
    Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
    id
    OG004
    title
    Part 2 (Randomized Period) Cohort 3-Placebo
  6. description
    Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG005
    title
    Part 2 (Randomized Period) Cohort 3- Eltrombopag
param Type
NUMBER
population Description
Intent-to-Treat (ITT) Population: all enrolled participants during Part 2. The ITT Population was the primary population used for assessing efficacy. Only evaluable participants were considered for analysis where participants with a Baseline platelet count \>10Gi/L was considered as evaluable.
reporting Status
POSTED
time Frame
From Day 8 up to Day 43 of Part 2
title
Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2)
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice