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New shot could help kids with bleeding disorder avoid bruising

NCT ID NCT07455006

Disease control Sponsor: Qilu Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests QL0911, a weekly injection, in 60 children aged 1 to 17 with chronic immune thrombocytopenia (ITP) who have low platelet counts. The goal is to see if the drug can safely raise platelet levels to reduce bleeding risk. Participants receive either QL0911 or a placebo, with doses adjusted based on weekly blood tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
QL0911 (a thrombopoietin receptor agonist given as a weekly injection)
What this could lead to
If it works, this could provide a new treatment option to safely raise platelet counts and reduce bleeding in children with chronic ITP.
What could go wrong
This is a relatively small trial (60 participants) and the drug may not work for all children. Side effects or the need for ongoing injections could limit its use.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

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

1 year to 17 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: 1. Age ≥ 1 years old and \< 18 years old. 2. Diagnosed primary ITP for at least 12 months; 3. Had received at least one first-line ITP treatment with no response or recurrence after treatment; 4. Had a platelet count \<30×10\^9/L within 48 hours before the first dose; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 6. Patients of child-bearing potential must agree to use effective contraception during the study and for 3 months following the last dose of study treatment. Exclusion Criteria: 1. Had a history of bone marrow stem cell abnormalities or myelodysplastic syndrome other than ITP-specific changes. 2. Underwent splenectomy within 12 weeks before the first dose; 3. Had received ITP treatments (including rescue treatment) within 2 weeks before the first dose; 4. Had received romiplostim (Nplate®) or eltrombopag (Revolade®), rhTPO or other agents that stimulate TPO receptors (also known as c-Mpl)within 4 weeks before the first dose; 5. Had received antibody-based therapies within 14 weeks before the first dose. 6. Patients with concurrent or past malignant disease. 7. Serum creatinine or total bilirubin \>1.5\*ULN) alanine transaminase (ALT) or aspartate transaminase (AST) \>3\* ULN. 8. Had received antibody-based therapies within 14 weeks before the first dose. 9. Had prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or activated partial thromboplastin time (APTT) exceeded 20% of the reference range of normal values.

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenia autoimmune thrombocytopenic purpura Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thrombocytopenia, immune

How to take part

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  1. 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 ↗

  2. A doctor treating you

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