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NCT00529568 · OUTCOME

Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C 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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

What was measured

Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.

Analysis population: Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase

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-2b 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 \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b 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 Phase253
Eltrombopag+Antiviral Therapy: DB Phase506

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase32Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase97Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.9
    estimate Comment
    The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0202
    p Value Comment
    Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata
    param Type
    Percentage difference in SVR
    param Value
    6.0
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.9
    estimate Comment
    The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0202
    p Value Comment
    Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata
    param Type
    Percentage difference in SVR
    param Value
    6.0
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        97
denoms
  1. counts
    1. group Id
      OG000
      value
      253
    2. group Id
      OG001
      value
      506
    units
    Participants
description
Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.
groups
  1. description
    Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b 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 \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b 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
NUMBER
population Description
Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase
reporting Status
POSTED
time Frame
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
title
Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice