New weekly shot shows promise for rare bleeding disorder
NCT ID NCT04428255
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new medicine called HBM9161, given as a weekly shot under the skin, for adults with primary immune thrombocytopenia (ITP) — a condition where the immune system destroys platelets, raising the risk of bleeding. The trial included 36 people who had not responded well to standard treatments. The main goal was to see if the drug could safely raise platelet counts to safer levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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36 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Aug 2021
- Lead sponsor
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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.
- Ages
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18 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.
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. ≥ 18 years of age at the screening visit, male or female. 2. Persistent or chronic ITP whose average number of platelet at the screening visit and pre-dose (at least 1 day apart) is \< 30 × 10\^9/L, and not \> 35 × 10\^9/L for any of two tests. No severe bleeding within 4 weeks prior to the screening visit. 3. Patients who have received and failed at least 1 first line of ITP therapy (glucocorticoids and/or intravenous gamma globulin), or who are contraindicated, intolerable, or refuse standard therapy. 4. Patients will be allowed to use a stable dose of concomitant drugs for the treatment of ITP. e.g., glucocorticoid, danazol, immunosuppressant (azathioprine, cyclosporine A, mycophenolate mofetil) and eltrombopag. Exclusion Criteria: 1. Other autoimmune systemic diseases other than ITP. 2. Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia. 3. Secondary ITP. 4. Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study. 5. Use of anticoagulants or any agents that have antiplatelet effect or can affect thrombopoiesis within 3 weeks prior to the first dose of the study drug. 6. Received blood transfusion within 1 week prior to the first dose of the study drug. 7. Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug. 8. Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug. 9. Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first does of the study drug. 10. Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the first does of the study drug. 11. Treated with splenectomy within 4 weeks prior to first dose of the study drug. 12. Any thromboembolic or embolic events within 12 months prior to the first does of the study drug. 13. Serum total IgG \< 700 mg/dL at the screening visit.
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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.
Contacts and locations
Locations
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Hematology hospital, Chinese academy of medical sciences
Tianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.