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

What Was Tested

This registered phase 3 trial tested 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): AMG 531 (experimental) and Placebo (placebo comparator).

Active investigational product.

The registry classes the interventions as biological and drug.

Who Took Part

62 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 completed as least 1 prior treatment for ITP (e.g., prednisone). 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:. Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: have had a splenectomy for any reason; 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.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Romiplostim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2005-04-07 with completion listed for 2006-12-01.

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 (PRO) and Health Resource Utilization (HRU) due to treatment with AMG 531.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 62 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.