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New pill could help ITP patients who failed standard treatments

NCT ID NCT07294365

Disease control Sponsor: Dizal Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests an experimental oral drug called DZD8586 (Birelentinib) in adults with primary immune thrombocytopenia (ITP) whose condition did not improve after at least one standard therapy. About 60 participants will receive one of three dose levels to see if it safely raises platelet counts. The study aims to find a new treatment option for people with persistent or chronic ITP.

What this could mean

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

Active substance
DZD8586 (Birelentinib)
What this could lead to
If it works, this could offer a new oral treatment option for people with ITP who have not responded to standard therapies.
What could go wrong
This is an early phase 2 trial with only 60 participants, so results may not apply to everyone. The drug may cause side effects or fail to improve platelet counts.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

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

Started

Jan 2026

Expected to finish

Dec 2027

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

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. Male and female participants ≥ 18 years of age. 2. Diagnosed with persistent or chronic primary ITP, and an average of two platelet counts \< 30 × 10⁹/L. 3. Have failed at least one standard treatment for ITP (glucocorticoids and/or IVIG). 4. Adequate bone marrow reserve and organ functions. 5. Willing to comply with contraceptive restrictions. Exclusion Criteria: 1. Have evidence of secondary causes of immune thrombocytopenia. 2. Have a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura. 3. Any of previous or current treatment prohibited by protocol. 4. Any of severe cardiac abnormalities. 5. Active infection. 6. Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases. 7. Known allergy to DZD8586 drug excipients or other chemical analogues. 8. Pregnant or breastfeeding female participants.

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Conditions

The condition(s) this trial relates to.

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.

Immune thrombocytopenia (ITP)

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

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

More trials for these conditions

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