An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP

What Was Tested

In this phase 3 trial, researchers set out to test Romiplostim.

This protocol will provide open label romiplostim to adult thrombocytopenic subjects.

Romiplostim will be administered by subcutaneous injection once per week.

It had 1 arm (groups): 1 (experimental).

Romiplostim.

The registry classes the interventions as biological.

Who Took Part

407 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: Subject is ≥ 18 years of age. Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines. If Subject is \> 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP. Subject has received at least 1 prior therapy for ITP. Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (mds), or bone marrow stem cell disorder; subject has participated in any study evaluating peg-rhumgdf, recombinant human thrombopoietin (rhutpo), or related platelet product; subject has a known hypersensitivity to any recombinant e coli-derived product.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-02-01 with completion listed for 2011-01-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Adverse Events (time frame: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks).

It also tracked 2 secondary outcomes, for example Platelet Response (Definition 1) and Platelet Response (Definition 2).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Romiplostim in 407 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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