New combo therapy offers hope for patients with stubborn low platelet disorder
NCT ID NCT07206823
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of two drugs, romiplostim and rituximab, in about 30 adults with primary immune thrombocytopenia (ITP) whose condition did not improve with standard oral treatments. Participants receive weekly injections of romiplostim and four weekly infusions of rituximab. The goal is to see if this combo can safely raise platelet counts and reduce bleeding symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 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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14 years and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Confirmed diagnosis of primary immune thrombocytopenia (ITP). Age ≥14 years. Prior exposure to at least one ITP-directed therapy (e.g., corticosteroids, intravenous immunoglobulin, recombinant human thrombopoietin, TPO-RAs, immunosuppressants, or splenectomy), including a minimum 4-week course of an oral TPO-RA (hetrombopag or eltrombopag) that was discontinued due to insufficient response. Platelet count \< 30 × 10⁹/L at screening, OR platelet count \< 50 × 10⁹/L with concurrent clinically significant bleeding. Stable glucocorticoid dose (e.g., prednisone or methylprednisolone, not exceeding 4 tablets daily) for at least 2 weeks, and stable dosing of any other immunosuppressants for at least 4 weeks prior to enrollment. No receipt of intravenous immunoglobulin within 2 weeks before the first dose of study treatment. No platelet transfusion within 1 week before the first dose of study treatment. Exclusion Criteria: Secondary ITP due to underlying conditions such as other autoimmune disorders, viral infections, or drug exposure. Presence of active malignancy, pregnancy, significant cardiovascular or cerebrovascular disease, or history of arterial/venous thrombosis.
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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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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, China