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NCT01143038 · FLOW

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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.

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
    FG000
    title
    Romiplostim
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Requirement for alternative therapy
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Protocol Deviation
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        75
      type
      STARTED
    2. achievements
      1. comment
        Defined as completion of romiplostim treatment
        group Id
        FG000
        num Subjects
        59
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study included a 12-month romiplostim treatment period, and a romiplostim dose-tapering period. Participants who maintained a platelet count of ≥ 50 x 10\^9/L in the absence of romiplostim and all medications for ITP (concomitant or rescue) were followed for at least 6 months to confirm the incidence of ITP remission.
recruitment Details
Ninety-eight adults with immune thrombocytopenia purpura (ITP) were screened for the study; 23 were considered screen failures. Seventy-five participants were enrolled at 32 study centers in Australia, the European Union, and North America from 30 November 2010 to 21 September 2012.
Complete source fields
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
    FG000
    title
    Romiplostim
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Requirement for alternative therapy
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Protocol Deviation
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        75
      type
      STARTED
    2. achievements
      1. comment
        Defined as completion of romiplostim treatment
        group Id
        FG000
        num Subjects
        59
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study included a 12-month romiplostim treatment period, and a romiplostim dose-tapering period. Participants who maintained a platelet count of ≥ 50 x 10\^9/L in the absence of romiplostim and all medications for ITP (concomitant or rescue) were followed for at least 6 months to confirm the incidence of ITP remission.
recruitment Details
Ninety-eight adults with immune thrombocytopenia purpura (ITP) were screened for the study; 23 were considered screen failures. Seventy-five participants were enrolled at 32 study centers in Australia, the European Union, and North America from 30 November 2010 to 21 September 2012.

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Preserved source evidence · Not medical advice