Participant flow

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.

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

   FG000

   title

   Romiplostim

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         67

      type

      Protocol-specified Criteria

   2. reasons

      1. group Id

         FG000

         num Subjects

         20

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Decision by Sponsor

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         203

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         203

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         79

      type

      Enrolled Under Protocol Supplement

   4. achievements

      1. group Id

         FG000

         num Subjects

         109

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         94

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

All participants were assigned to receive weekly romiplostim. A subset of participants enrolled under a protocol supplement in the European Union (EU), Switzerland, and Turkey were enrolled into the following 2 cohorts: * bone marrow biopsy and aspirate at baseline and year 1 * bone marrow biopsy and aspirate at baseline and year 2

recruitment Details

Children with immune thrombocytopenic purpura (ITP) and platelet counts ≤ 30×10⁹/L or uncontrolled bleeding were enrolled from December 2014 to August 2016 at 66 centers in 16 countries worldwide, including Eastern Europe (44%), Western Europe (25%), and US/Canada (21%).

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Preserved source evidence · Not medical advice