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Real-World data may reveal which ITP treatments work best

NCT ID NCT07805408

Knowledge-focused Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This study looks back at health records from over 3,700 adults with immune thrombocytopenia (ITP), a condition where the immune system destroys blood platelets, raising bleeding risk. Researchers want to see which second-line treatments doctors prescribe after first-line steroids fail, and how long patients stay on those treatments. They will compare options like romiplostim, eltrombopag, rituximab, and splenectomy using a large US database of electronic health records and insurance claims. The goal is to understand real-world effectiveness and treatment patterns, not to test a new drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
This study could help doctors understand which second-line treatments for immune thrombocytopenia work best in everyday practice, guiding better care decisions.
What could go wrong
Because this is a retrospective database study, it can show patterns but cannot prove cause and effect. The results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

3,714 people

The number who actually took part.

Started

May 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients diagnosed with primary ITP from a US medical claim and EHR data source during the study period.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Evidence of a diagnosis of primary ITP during the study identification period. 2. Evidence of treatment with any allowed second-line treatment during the study identification period after the first primary ITP diagnosis. 3. Evidence of treatment with any allowed first-line treatment prior to index. 4. Aged ≥18 years at index. Exclusion criteria 1. Fewer than 12 months continuous enrollment or activity prior to index. 2. Fewer than one inpatient or fewer than two outpatient records during baseline. 3. Evidence of any allowed second-line therapies or splenectomy prior to index. 4. 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. 5. Continuous enrollment end date or death date prior to index.

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune thrombocytopenia

Contacts and locations

Locations

  • Novartis

    East Hanover, New Jersey, 07936, United States

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