Primary Immune Thrombocytopenia Treated with Romiplostim (20140451)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ROMIPLOSTIM
• Medical condition to be studied:
  Immune thrombocytopenia

Population studied

• Short description of the study population:
  Adult patients within the United Kingdom Immune Thrombocytopenia (UKITP) Registry diagnosed with primary Immune Thrombocytopenia (ITP) and who had received at least 1 dose of romiplostim after launch in the United Kingdom in October 2009.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Immune thrombocytopenic purpura patients
• Estimated number of subjects:
  130

Study design details

• Main study objective:
  · Describe the demographic and clinical characteristics of patient who have received romiplostim at the time of romiplostim initiation.; · Describe ITP medication use since diagnosis and platelet counts prior to and post-romiplostim initiation in the study population.
• Outcomes:
  Demographic (sex, age, ethnicity) and clinical characteristics (specific comorbidities, diagnosis details) will be described using descriptive statistics. ; ITP therapies since diagnosis will be described and platelet counts at romiplostim initiation and after will be summarised. ; The pattern of romiplostim administration will be described.Rate of bleeding events, hospitalisations and use of rescue medications will also be described
• Data analysis plan:
  The data analysis for this study will be descriptive in nature. ; Endpoints/variables of a binary nature, will be summarised as a proportion. Endpoints/variables of a continuous nature will be summarized using the mean, standard deviation, median and interquartile range, minimum and maximum value. ; For measuring rate of events of interest in person-time, the number of events during thetime at risk will be divided by the total person-time at risk. 95% confidence interval (Poisson) will be generated for each estimate.

Documents

Study results

01.09.01 Clinical Study Report 2016-12-14 20140451 Final report_abstract (pages 8-11)