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NCT02279173 · OUTCOME

Number of Participants Who Developed Anti-Romiplostim or Anti-Thrombopoietin Neutralizing Antibodies

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP) · Source last updated 2022-06-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Week 12, week 52 and every 24 weeks thereafter up to month 36

What was measured

Blood samples were first tested for the presence of binding antibodies to romiplostim or the peptide portion of romiplostim, and to endogenous thrombopoietin (eTPO). Samples testing positive for binding antibodies were then tested for neutralizing antibodies by assessing their ability to neutralize romiplostim and/or eTPO in a cell-based bioassay. Participants who developed neutralizing antibodies are those who had a postbaseline positive result with a negative or no result at baseline. Transient is defined as a negative result at the participant's last time point tested within the study period.

Analysis population: Participants who received at least 1 dose of romiplostim and with a post-baseline antibody result.

Groups in this outcome

Romiplostim

Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.

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

Analysis denominator · Participants

GroupSource count
Romiplostim203

Reported measurements

Anti-romiplostim neutralizing antibodies
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim7Not reportedNot reportedNot reportedNot reported
Transient anti-romiplostim neutralizing antibodies
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim4Not reportedNot reportedNot reportedNot reported
Anti-eTPO neutralizing antibodies
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim1Not reportedNot reportedNot reportedNot reported
Transient anti-eTPO neutralizing antibodies
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Anti-romiplostim neutralizing antibodies
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Transient anti-romiplostim neutralizing antibodies
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Anti-eTPO neutralizing antibodies
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Transient anti-eTPO neutralizing antibodies
denoms
  1. counts
    1. group Id
      OG000
      value
      203
    units
    Participants
description
Blood samples were first tested for the presence of binding antibodies to romiplostim or the peptide portion of romiplostim, and to endogenous thrombopoietin (eTPO). Samples testing positive for binding antibodies were then tested for neutralizing antibodies by assessing their ability to neutralize romiplostim and/or eTPO in a cell-based bioassay. Participants who developed neutralizing antibodies are those who had a postbaseline positive result with a negative or no result at baseline. Transient is defined as a negative result at the participant's last time point tested within the study period.
groups
  1. description
    Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
    id
    OG000
    title
    Romiplostim
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who received at least 1 dose of romiplostim and with a post-baseline antibody result.
reporting Status
POSTED
time Frame
Week 12, week 52 and every 24 weeks thereafter up to month 36
title
Number of Participants Who Developed Anti-Romiplostim or Anti-Thrombopoietin Neutralizing Antibodies
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice