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Triple-Drug combo aims to stop bleeding disorder in its tracks

NCT ID NCT07189910

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a three-step treatment for adults with severe immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding. Participants first get steroids and a platelet-boosting protein in the hospital, then switch to an oral drug (eltrombopag) for 10 weeks at home. The goal is to see if this sequence leads to more stable platelet counts and fewer relapses compared to standard care. 150 people will take part.

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 glucocorticoids (high-dose dexamethasone), recombinant human thrombopoietin (rhTPO), and eltrombopag olamine (a platelet-boosting drug)
What this could lead to
If successful, this sequential treatment strategy could offer a more effective way to quickly raise platelet counts and maintain them long-term in adults with severe ITP, reducing the need for repeated hospitalizations.
What could go wrong
This is a phase 4 study, so the drugs are already approved, but the specific combination and sequence are new. It may not work better than existing treatments, and side effects from the drugs (e.g., infection risk from steroids, liver issues from eltrombopag) are possible.

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 150 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 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

12 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: * Age between 12 and 75 years, regardless of gender; * ECOG performance status of 0-1; * Diagnosis of primary ITP confirmed by bone marrow biopsy (valid within 3 months) and other relevant assessments; baseline platelet count (PLT) \<20×10⁹/L within 48 hours prior to administration of study medication; * Adequate function of major organs as defined below (based on the clinical laboratory reference ranges of the study center): * Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; no abnormalities unrelated to ITP, except a) PLT \<20×10⁹/L at Day 1 or within 48 hours of Day 1 is allowed; b) Hemoglobin: If anemia is clearly due to ITP-related bleeding, hemoglobin lower than the lower limit of normal (LLN) may be permitted at investigator's discretion. * Biochemistry: Total bilirubin (TBIL) ≤1.5×ULN; ALT, AST, ALP ≤3×ULN; serum creatinine ≤1.5×ULN and creatinine clearance ≥50 mL/min. * Coagulation: Prothrombin time (PT) within ±3 seconds of normal range; activated partial thromboplastin time (APTT) ≤1.5×ULN unless on medications known to alter INR/APTT; no known history of coagulopathy other than ITP. * Prior ITP rescue treatments (e.g., platelet transfusion, IVIG, immunomodulators, cyclophosphamide) must have ended or failed at least 2 weeks prior to enrollment (except corticosteroids); TPO-RAs or corticosteroids must be discontinued ≥14 days before study start. * Patients on maintenance immunosuppressive therapy (e.g., corticosteroids, azathioprine, danazol, cyclosporine A, mycophenolate mofetil, or traditional Chinese platelet-raising medicine) must be on stable doses for at least 1 month prior to enrollment. Patients previously treated with anti-CD20 antibodies must have discontinued at least 6 months prior; splenectomy patients may enroll ≥6 months post-surgery. * Female subjects of childbearing potential must have a negative serum pregnancy test within 24 hours prior to first dosing; all subjects agree to use effective contraception during the study and for 6 months after its completion. * No known contraindications to corticosteroids, rhTPO, or eltrombopag and willing to undergo rhTPO followed by eltrombopag treatment. * Willingness to participate and ability to provide written informed consent. For participants aged ≥12 years, both the subject and their legal guardian must sign the informed consent form. Exclusion Criteria: * Refractory ITP (failure to respond to first- and second-line TPO-RAs, anti-CD20 therapy, or splenectomy); * Pregnant or lactating women; * Evidence of secondary ITP (e.g., untreated Helicobacter pylori, leukemia, lymphoma, autoimmune diseases such as SLE, Hashimoto's thyroiditis), drug-induced thrombocytopenia (e.g., due to anticonvulsants, antibiotics, heparin), or multi-lineage autoimmune cytopenias (e.g., Evans syndrome); * History or presence of any primary disease other than ITP that may cause thrombocytopenia (e.g., myelodysplastic syndrome, congenital bone marrow failure syndromes such as Fanconi anemia or dyskeratosis congenita, aplastic anemia), as judged by the investigator; * History of intracranial hemorrhage or severe bleeding (\>CTCAE Grade 3) of vital organs; symptomatic gastrointestinal bleeding (e.g., hematemesis, melena) within 6 months prior to screening (asymptomatic occult blood and hemorrhoids excluded); * History of any arterial or venous thrombosis (e.g., stroke, TIA, MI, DVT, PE) within 6 months prior to enrollment and at least two of the following risk factors: hormone replacement therapy, oral contraceptives (including estrogens), smoking, diabetes, hypercholesterolemia, pharmacologically controlled hypertension, hereditary thrombophilia; * Severe cardiovascular disease within 6 months prior to enrollment (e.g., NYHA Class III-IV), arrhythmias increasing thrombotic risk (e.g., atrial fibrillation), or history of coronary stenting, angioplasty, or bypass surgery; * Concurrent serious or life-threatening malignancy; * Use of drugs that significantly affect platelet function (e.g., aspirin, clopidogrel, NSAIDs) or anticoagulants for \>3 days within 2 weeks before and during the study; * Use of any herbal medicine or nutritional supplement within 1 week prior to study start, except for vitamins and minerals; * Ongoing or uncontrolled serious infections (≥CTCAE Grade 2); * Laboratory or clinical evidence of HIV infection, active hepatitis C, active hepatitis B, or previous history of these infections. Patients with positive HBsAg are excluded. Those with HBsAg-negative but HBcAb-positive must undergo HBV DNA testing; if positive, they are excluded; * Any condition deemed by the investigator to make the subject unsuitable for participation, including but not limited to medical, social, or psychological factors affecting safety or study compliance.

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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.

  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.

    Open the record ↗

  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

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022,, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.