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New weekly shot shows promise for rare bleeding disorder

NCT ID NCT04428255

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

36 people

The number who actually took part.

Started

Jul 2020

Finished

Aug 2021

Lead sponsor

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

18 years and older

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. ≥ 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

  • 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.