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NCT00516321 · OUTCOME

Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) 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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From Baseline up to Week 12

What was measured

EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.

Analysis population: ITT Population

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 Phase232
Eltrombopag+Antiviral Therapy: DB Phase450

Reported measurements

EVR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase115Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase297Not reportedNot reportedNot reportedNot reported
cEVR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase60Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase187Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        297
    title
    EVR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        187
    title
    cEVR
denoms
  1. counts
    1. group Id
      OG000
      value
      232
    2. group Id
      OG001
      value
      450
    units
    Participants
description
EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.
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
NUMBER
population Description
ITT Population
reporting Status
POSTED
time Frame
From Baseline up to Week 12
title
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice