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