P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

What Was Tested

The trial (phase 3) is built around Romiplostim.

It had two arms (groups): AMG 531 (placebo comparator) and Placebo (placebo comparator).

Double blinded placebo-controlled study.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 34 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Subjects must be ≥ 20 years of age at the time of obtaining the informed consent. Have received at least 1 prior treatment for ITP. If known Helicobacter pylori positive, having completed one course of Helicobacter pylori eradication therapy at least 12 weeks before the first screening visit.

The full record lists 9 inclusion and 16 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; documented diagnosis of anti phospholipid antibody syndrome; have had a splenectomy for any reason within 12 weeks before the first screening visit.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Romiplostim.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2007-10-01 with completion listed for 2009-04-13.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Weeks With Weekly Platelet Response (time frame: 12 weeks (Weeks 2 - 13)).

It also tracked 4 secondary outcomes, for example Change From Baseline in Mean of Last 4 Weekly Platelet Counts, Weeks With Platelet Count Between 50 and 200 and Rescue Medication(s).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 34 people.

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

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.