Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)

What Was Tested

The trial (phase 1, phase 2) is built around Romiplostim.

It had two arms (groups): one (experimental) and one (experimental).

The administration of Romiplostim will be performed on Day 1 and 8.

The administration of Romiplostim will be performed on Day 1 and 8.

The registry classes the interventions as drug.

Who Took Part

The registry lists 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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 and ≤ 70 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 typical of itp; had received eltrombopag, recombinant human thrombopoietin (rhutpo) or other myeloproliferative leukemia (mpl) stimulation product; 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Romiplostim group and the comparison group should start out alike.

The Romiplostim group and the comparison group ran side by side rather than switching.

Being open-label, the Romiplostim study did not mask who received what.

It started in 2015-09 with completion listed for 2017-08.

It ran at 5 sites in China (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The incidence of all adverse events including evaluation of antidrug antibody status.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Romiplostim in 16 people.

Its size is small, so on its own it can only give an early look.

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.