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NCT01143038 · OUTCOME

Number of Participants Who Developed Antibodies to Romiplostim

Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim · Source last updated 2022-09-21

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
Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)

What was measured

The number of participants who developed antibody formation (defined as negative at baseline and positive at post-baseline, transient or persistent) to romiplostim, endogenous thrombopoietin (eTPO), and thrombopoietin mimetic peptide (TMP, the peptide component of romiplostim) was summarized.

Analysis population: Safety analysis set participants with available results

Groups in this outcome

Romiplostim

Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.

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

Analysis denominator · Participants

GroupSource count
Romiplostim69

Reported measurements

Antibodies to romiplostim
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim2Not reportedNot reportedNot reportedNot reported
Antibodies to TPO
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim1Not reportedNot reportedNot reportedNot reported
Antibodies to TMP
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim2Not reportedNot reportedNot reportedNot reported
Neutralizing antibodies to romiplostim
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim1Not reportedNot reportedNot reportedNot reported
Neutralizing antibodies to TPO
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim0Not reportedNot reportedNot reportedNot reported
Neutralizing antibodies to TMP
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Antibodies to romiplostim
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Antibodies to TPO
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Antibodies to TMP
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Neutralizing antibodies to romiplostim
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Neutralizing antibodies to TPO
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Neutralizing antibodies to TMP
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    units
    Participants
description
The number of participants who developed antibody formation (defined as negative at baseline and positive at post-baseline, transient or persistent) to romiplostim, endogenous thrombopoietin (eTPO), and thrombopoietin mimetic peptide (TMP, the peptide component of romiplostim) was summarized.
groups
  1. description
    Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.
    id
    OG000
    title
    Romiplostim
param Type
NUMBER
population Description
Safety analysis set participants with available results
reporting Status
POSTED
time Frame
Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)
title
Number of Participants Who Developed Antibodies to Romiplostim
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice