AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy

What Was Tested

The trial (phase 3) is built around Romiplostim.

This study will also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.

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

Active Investigational Product.

The registry classes the interventions as biological and drug.

Who Took Part

63 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: Diagnosis of ITP according to American Society of Hematology (ASH) guidelines (Appendix F). Have had a splenectomy for the treatment of ITP greater than or equal to 24 weeks prior to study entry. Subjects greater than 60 years of age must have a documented history of chronic ITP with a bone marrow report to confirm the diagnosis. The platelet count (calculated from the mean of the 2 counts taken during the screening and pre-treatment periods) must be:. \* less than 30 x 10\^9/L for those subjects not receiving any ITP therapy, with no count greater than 35 x 10\^9/L,.

The full record lists 10 inclusion and 19 exclusion criteria; among the exclusions: documented diagnosis of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) in the past year; history of venous thrombosis (i.e., deep vein thrombosis, pulmonary embolism) including those subjects who are on ant-coagulation therapy; known positive test for human immunodeficiency virus (hiv) infection or hepatitis c virus.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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 2005-03-29 with completion listed for 2006-09-01.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example To evaluate the overall safety of AMG 531 and To evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 63 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.