Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)

What Was Tested

This registered phase 3 trial tested Romiplostim.

It had two arms (groups): Placebo (placebo comparator) and Drug (experimental).

Subjects received placebo for injection treatment will be administered subcutaneously once a week.

Subjects received Romiplostim for injection treatment will be administered subcutaneously once a week.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 203 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosed with immune thrombocytopenia (ITP) for at least 6 months prior to signing the informed consent form (ICF). Subject is ≥ 18 years old while signing the ICF. The mean of 3 scheduled platelet counts taken during the screening period must be: \< 30 ×10\^9/L, with none \>35×10\^9/L.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: any known history of bone marrow stem cell disorder. any abnormal bone marrow findings other than those typical of itp; received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the icf; received myeloproliferative leukemia (mpl) stimulation product other than the subject who had suspended recombinant human thrombopoietin (rhutpo) for injection for 4 weeks before signing icf.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Romiplostim and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Romiplostim study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2015-09 with completion listed for 2017-02.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 203 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.