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NCT00529568 · OUTCOME

Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)

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

There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.

Analysis population: Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study. Only those participants who were analyzed for SVR and RVR were considered.

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 Phase105
Eltrombopag+Antiviral Therapy: DB Phase205

Reported measurements

SVR, rs12979860 (CC), R; n=12, 50
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase10Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase28Not reportedNot reportedNot reportedNot reported
SVR, rs12979860 (CC), NR; n=105, 205
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase24Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase58Not reportedNot reportedNot reportedNot reported
SVR, rs12979860 (CT), R; n=12, 50
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase18Not reportedNot reportedNot reportedNot reported
SVR, rs12979860 (CT), NR; n=105, 205
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase60Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase111Not reportedNot reportedNot reportedNot reported
SVR, rs12979860 (TT), R; n=12, 50
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase4Not reportedNot reportedNot reportedNot reported
SVR, rs12979860 (TT), NR; n=105, 205
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase21Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase36Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (TT), R; n=12, 50
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase11Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase36Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (TT), NR; n=105, 205
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase48Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase89Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (GT), R; n=12, 50
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase13Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (GT), NR; n=105, 205
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase51Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase99Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (GG), R; n=12, 50
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (GG), NR; n=105, 205
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase6Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase17Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (CC), R; n=11, 33
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase6Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase21Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (CC), NR; n=106, 222
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase28Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase65Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (CT), R; n=11, 33
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase11Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (CT), NR; n=106, 222
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase57Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase118Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (TT), R; n=11, 33
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (TT), NR; n=106, 222
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase21Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase39Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (TT), R, n=11, 33
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase9Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase28Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (TT), NR; n=106, 222
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase50Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase97Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (GT), R; n=11, 33
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase5Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (GT), NR; n=106, 222
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase50Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase107Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (GG), R; n=11, 33
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase0Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (GG), R; n=106, 222
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase6Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        28
    title
    SVR, rs12979860 (CC), R; n=12, 50
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        58
    title
    SVR, rs12979860 (CC), NR; n=105, 205
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        18
    title
    SVR, rs12979860 (CT), R; n=12, 50
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        111
    title
    SVR, rs12979860 (CT), NR; n=105, 205
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
    title
    SVR, rs12979860 (TT), R; n=12, 50
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        36
    title
    SVR, rs12979860 (TT), NR; n=105, 205
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        36
    title
    SVR, rs8099917 (TT), R; n=12, 50
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        89
    title
    SVR, rs8099917 (TT), NR; n=105, 205
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        13
    title
    SVR, rs8099917 (GT), R; n=12, 50
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        99
    title
    SVR, rs8099917 (GT), NR; n=105, 205
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    SVR, rs8099917 (GG), R; n=12, 50
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        17
    title
    SVR, rs8099917 (GG), NR; n=105, 205
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    2. group Id
      OG001
      value
      205
    units
    Participants
description
There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.
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
Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study. Only those participants who were analyzed for SVR and RVR were considered.
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 Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice