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NCT00908037 · OUTCOME

Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline 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
Participants
Interval / dispersion
Not reported
Time frame
From Baseline up to Study Week 24 of Part 1

What was measured

Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with a positive result at any time post Baseline were reported. A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.

Analysis population: Safety 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

Epithelial Renal Cell Casts
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 (Dose-Finding Period) Cohort 10Not reportedNot reportedNot reportedNot reported
Part 1 (Dose-Finding Period) Cohort 20Not reportedNot reportedNot reportedNot reported
Part 1 (Dose-Finding Period) Cohort 32Not reportedNot reportedNot reportedNot reported
RBC Casts
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 (Dose-Finding Period) Cohort 10Not reportedNot reportedNot reportedNot reported
Part 1 (Dose-Finding Period) Cohort 20Not reportedNot reportedNot reportedNot reported
Part 1 (Dose-Finding Period) Cohort 30Not reportedNot reportedNot reportedNot reported
WBC Casts
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 (Dose-Finding Period) Cohort 10Not reportedNot reportedNot reportedNot reported
Part 1 (Dose-Finding Period) Cohort 20Not reportedNot reportedNot reportedNot reported
Part 1 (Dose-Finding Period) Cohort 30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
    title
    Epithelial Renal Cell Casts
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    RBC Casts
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    WBC Casts
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with a positive result at any time post Baseline were reported. A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.
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
Safety Population, only those participants enrolled during Part 1 were analyzed.
reporting Status
POSTED
time Frame
From Baseline up to Study Week 24 of Part 1
title
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice