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CompletedNo phase

A Real World Study of Treatment Patterns and Effectiveness of Standard of Care in Primary Immune Thrombocytopenia Patients

Key facts

Who runs it
Novartis Pharmaceuticals
Where
East Hanover, United StatesSee the site
Trial code
Status
Completed
People taking part
3,714 people enrolled
Started
16 May 2025
Ended
11 Nov 2025
Type of study
Observational
Record updated
4 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Evidence of a diagnosis of primary ITP during the study identification period
  • Evidence of treatment with any allowed second-line treatment during the study identification period after the first primary ITP diagnosis
  • Evidence of treatment with any allowed first-line treatment prior to index
  • Aged ≥18 years at index

Who cannot take part

  • Fewer than 12 months continuous enrollment or activity prior to index
  • Evidence of any allowed second-line therapies or splenectomy prior to index
  • Evidence of diagnosis of Evans syndrome, systemic lupus erythematosus, autoimmune lymphoproliferative syndrome, human immunodeficiency virus (HIV), hepatitis C virus (HCV), Helicobacter pylori, Sjogren's antiphospholipid syndrome prior to index, or active b-cell malignancies (not in remission) in the baseline period
  • Continuous enrollment end date or death date prior to index
  • Fewer than one inpatient or fewer than two outpatient records during baseline

Where in United States

  • NovartisEast Hanover, United StatesNo longer taking part

About the trial

What the trial wants to find out

The aim of this study was to describe real-world treatment patterns and standard of care treatment effectiveness and utilization outcomes in adult primary ITP patients indicated for second-line treatment with any prior corticosteroid treatment in real-world treatment settings in the United States (US) identified in an electronic health record (EHR) and claims database.

The group in the trial

  • ITP Cohort

    Primary ITP patients with prior corticosteroid treatment being treated with second-line treatment.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Treatment Patterns and Real World Effectiveness of Standard of Care in Primary Immune Thrombocytopenia (ITP) Patients: A Real-world Retrospective Cohort Study Using the Optum® Market Clarity Database
Record updated
4 September 2026