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NCT00516321 · OUTCOME

Number of Participants (Par.) 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) 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 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. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms 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

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 Phase99
Eltrombopag+Antiviral Therapy: DB Phase181

Reported measurements

SVR, rs12979860 (CC), R; n=12, 36
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase18Not reportedNot reportedNot reportedNot reported
SVR, rs12979860 (CC), NR; n=99, 168
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase21Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase38Not reportedNot reportedNot reportedNot reported
SVR, rs12979860 (CT), R; n=12, 36
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
SVR, rs12979860 (CT), NR; n=99, 168
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase63Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase95Not reportedNot reportedNot reportedNot reported
SVR, rs12979860 (TT), R; n=12, 36
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
SVR, rs12979860 (TT), NR; n=99, 168
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase15Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase35Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (TT), R; n=12, 36
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase7Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase26Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (TT), NR; n=99, 166
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase50Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase70Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (GT), R; n=12, 36
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase9Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (GT), NR; n=99, 166
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase42Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase75Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (GG), R; n=12, 36
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
SVR, rs8099917 (GG), NR; n=99, 166
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase7Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase21Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (CC), R; n=16, 23
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase7Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase12Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (CC), NR; n=95, 181
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase19Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase44Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (CT), R; n=16, 23
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase7Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase10Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (CT), NR; n=95, 181
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase62Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase102Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (TT), R; n=16, 23
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
RVR, rs12979860 (TT), NR; n=95, 181
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase14Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase35Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (TT), R, n=16, 23
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase10Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase14Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (TT), NR; n=95, 179
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase47Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase82Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (GT), R; n=16, 23
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase9Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (GT), NR; n=95, 179
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase42Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase75Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (GG), R; n=16, 23
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase0Not reportedNot reportedNot reportedNot reported
RVR, rs8099917 (GG), NR; n=95, 179
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase6Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        18
    title
    SVR, rs12979860 (CC), R; n=12, 36
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        38
    title
    SVR, rs12979860 (CC), NR; n=99, 168
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        17
    title
    SVR, rs12979860 (CT), R; n=12, 36
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        95
    title
    SVR, rs12979860 (CT), NR; n=99, 168
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    SVR, rs12979860 (TT), R; n=12, 36
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        35
    title
    SVR, rs12979860 (TT), NR; n=99, 168
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        26
    title
    SVR, rs8099917 (TT), R; n=12, 36
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        70
    title
    SVR, rs8099917 (TT), NR; n=99, 166
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        9
    title
    SVR, rs8099917 (GT), R; n=12, 36
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        75
    title
    SVR, rs8099917 (GT), NR; n=99, 166
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    SVR, rs8099917 (GG), R; n=12, 36
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        21
    title
    SVR, rs8099917 (GG), NR; n=99, 166
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      181
    units
    Participants
description
There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms 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-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
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
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 (Par.) 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) During the DB Phase
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice