NCT00516321 · 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 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

Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 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-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

Group	Source count
Placebo+Antiviral Therapy: DB Phase	232
Eltrombopag+Antiviral Therapy: DB Phase	450

Reported measurements

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo+Antiviral Therapy: DB Phase	33	Not reported	Not reported	Not reported	Not reported
Eltrombopag+Antiviral Therapy: DB Phase	104	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
2.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
13.4
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
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0064
p Value Comment
Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata
param Type
Percentage difference in SVR
param Value
7.9
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
2.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
13.4
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
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0064
p Value Comment
Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata
param Type
Percentage difference in SVR
param Value
7.9
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
33
group Id
OG001
value
104

denoms

counts
group Id
OG000
value
232
group Id
OG001
value
450
units
Participants

description

Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.

groups

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
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

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

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Preserved source evidence · Not medical advice