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NCT00516321 · OUTCOME

Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in 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 9 in the OL Phase

What was measured

In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was \<90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained \<90 Gi/L. Participants who achieved platelet count \>=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.

Analysis population: Safety Population. Participants with a platelet count \>=90 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.

Groups in this outcome

Eltrombopag: OL Phase

Participants with a platelet count of \<75 giga (10\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \>=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Eltrombopag: OL Phase680

Reported measurements

25 mg
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag: OL Phase451Not reportedNot reportedNot reportedNot reported
50 mg
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag: OL Phase176Not reportedNot reportedNot reportedNot reported
75 mg
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag: OL Phase39Not reportedNot reportedNot reportedNot reported
100 mg
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag: OL Phase14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        451
    title
    25 mg
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        176
    title
    50 mg
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        39
    title
    75 mg
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    100 mg
denoms
  1. counts
    1. group Id
      OG000
      value
      680
    units
    Participants
description
In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was \<90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained \<90 Gi/L. Participants who achieved platelet count \>=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.
groups
  1. description
    Participants with a platelet count of \<75 giga (10\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \>=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
    id
    OG000
    title
    Eltrombopag: OL Phase
param Type
NUMBER
population Description
Safety Population. Participants with a platelet count \>=90 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.
reporting Status
POSTED
time Frame
From Baseline up to Week 9 in the OL Phase
title
Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice