Can a Triple-Drug attack tame immune thrombocytopenia?

NCT ID NCT07788456

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial is testing whether a combination of standard steroids, a platelet-boosting drug (TPO-RA), and targeted antibodies (rituximab or anti-CD38) can improve outcomes for adults newly diagnosed with immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding risk. Participants first receive steroids plus a TPO-RA for 12 weeks. If their platelet count doesn't improve, they then receive additional targeted therapy. The study will measure how many patients achieve a sustained platelet response over 24 weeks, aiming to find a more effective initial treatment strategy.

What this could mean

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

Active substance
A combination of standard-dose corticosteroids (methylprednisolone or prednisone), a thrombopoietin receptor agonist (TPO-RA) such as hetrombopag or eltrombopag, and, for those who don't respond, rituximab or an anti-CD38 monoclonal antibody.
What this could lead to
If successful, this approach could offer a more effective first-line strategy for newly diagnosed ITP, potentially reducing the need for rescue therapies and improving long-term platelet control.
What could go wrong
This is a small, exploratory, single-arm trial, so results may not be generalizable. Combination therapy carries risks of immunosuppression, infection, and other side effects, and the optimal regimen is still uncertain.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 years

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. Age ≥18 years. 2. Confirmed newly diagnosed primary ITP with a platelet count \<30 × 10\^9/L. 3. No prior ITP-related treatment before enrollment, except for standard-dose corticosteroids and/or IVIG for ≤5 days. 4. Able to understand the study and provide signed informed consent.- Exclusion Criteria: 1. Use of corticosteroids or immunosuppressants for a non-ITP condition within 3 months. 2. Contraindication to corticosteroid therapy. 3. Arterial or venous thromboembolic event within 3 months. 4. Pregnant or breastfeeding women. 5. Current treatment with another investigational drug. 6. Any other medical history or condition that, in the investigator's judgment, makes the participant unsuitable for the study. \-

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura Purpura, Thrombocytopenic, Idiopathic

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ethics Committee of Hematology Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, 300020, China

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