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NCT00516321 · OUTCOME

Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease · Source last updated 2013-11-05

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

Measure
MEAN
Unit
Kilograms (kg)
Interval / dispersion
Standard Deviation
Time frame
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

What was measured

The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Analysis population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.

Groups in this outcome

Placebo+Antiviral Therapy: DB Phase

Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).

Eltrombopag+Antiviral Therapy: DB Phase

Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo+Antiviral Therapy: DB Phase230
Eltrombopag+Antiviral Therapy: DB Phase443

Reported measurements

Week 1, n=230, 443
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.51.83Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.61.76Not reportedNot reportedNot reported
Week 2, n=227, 439
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.71.95Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.71.87Not reportedNot reportedNot reported
Week 4, n=218, 430
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.82.16Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.02.39Not reportedNot reportedNot reported
Week 6, n=198, 421
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.02.30Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.22.33Not reportedNot reportedNot reported
Week 8, n=191, 416
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.22.63Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.72.68Not reportedNot reportedNot reported
Week 12, n=165, 404
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.43.27Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.33.15Not reportedNot reportedNot reported
Week 16, n=139, 377
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.83.15Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.83.19Not reportedNot reportedNot reported
Week 20, n=135, 364
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.03.74Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.33.62Not reportedNot reportedNot reported
Week 24, n=88, 249
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.73.59Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.13.88Not reportedNot reportedNot reported
Week 28, n=74, 202
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.54.79Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.43.96Not reportedNot reportedNot reported
Week 32, n=69, 184
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.83.70Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.24.01Not reportedNot reportedNot reported
Week 36, n=68, 175
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.93.81Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.44.07Not reportedNot reportedNot reported
Week 40, n=64, 169
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.84.10Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.54.30Not reportedNot reportedNot reported
Week 44, n=65, 166
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.04.40Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.74.35Not reportedNot reportedNot reported
End of Treatment, n=214, 419
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.03.88Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.24.65Not reportedNot reportedNot reported
4-week FU, n=204, 404
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.03.95Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.74.68Not reportedNot reportedNot reported
12-week FU, n=198, 401
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.44.51Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.95.07Not reportedNot reportedNot reported
24-week FU, n=197, 393
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.75.32Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.85.14Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.83
        value
        -0.5
      2. group Id
        OG001
        spread
        1.76
        value
        -0.6
    title
    Week 1, n=230, 443
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.95
        value
        -0.7
      2. group Id
        OG001
        spread
        1.87
        value
        -0.7
    title
    Week 2, n=227, 439
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.16
        value
        -0.8
      2. group Id
        OG001
        spread
        2.39
        value
        -1.0
    title
    Week 4, n=218, 430
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.30
        value
        -1.0
      2. group Id
        OG001
        spread
        2.33
        value
        -1.2
    title
    Week 6, n=198, 421
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.63
        value
        -1.2
      2. group Id
        OG001
        spread
        2.68
        value
        -1.7
    title
    Week 8, n=191, 416
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.27
        value
        -1.4
      2. group Id
        OG001
        spread
        3.15
        value
        -2.3
    title
    Week 12, n=165, 404
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.15
        value
        -1.8
      2. group Id
        OG001
        spread
        3.19
        value
        -2.8
    title
    Week 16, n=139, 377
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.74
        value
        -2.0
      2. group Id
        OG001
        spread
        3.62
        value
        -3.3
    title
    Week 20, n=135, 364
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.59
        value
        -1.7
      2. group Id
        OG001
        spread
        3.88
        value
        -4.1
    title
    Week 24, n=88, 249
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.79
        value
        -2.5
      2. group Id
        OG001
        spread
        3.96
        value
        -4.4
    title
    Week 28, n=74, 202
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.70
        value
        -1.8
      2. group Id
        OG001
        spread
        4.01
        value
        -4.2
    title
    Week 32, n=69, 184
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.81
        value
        -1.9
      2. group Id
        OG001
        spread
        4.07
        value
        -4.4
    title
    Week 36, n=68, 175
denoms
  1. counts
    1. group Id
      OG000
      value
      230
    2. group Id
      OG001
      value
      443
    units
    Participants
description
The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
dispersion Type
Standard Deviation
groups
  1. description
    Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
    id
    OG000
    title
    Placebo+Antiviral Therapy: DB Phase
  2. description
    Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
    id
    OG001
    title
    Eltrombopag+Antiviral Therapy: DB Phase
param Type
MEAN
population Description
Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.
reporting Status
POSTED
time Frame
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
title
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase
type
SECONDARY
unit Of Measure
Kilograms (kg)

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

Preserved source evidence · Not medical advice