Can a Triple-Drug attack tame immune thrombocytopenia?
NCT ID NCT07788456
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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Ethics Committee of Hematology Hospital, Chinese Academy of Medical Sciences
RECRUITINGTianjin, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New combo therapy aims to boost platelets in ITP patients
- Stem cell trial for rare bleeding disorder pulled before it began
- Gene-Edited immune cells take on autoimmune blood diseases
- New combo aims to free ITP patients from lifelong medication
- New drug OM336 aims to tame overactive immune system
- Promising ITP drug trial pulled before it even started