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New combo therapy shows promise for rare bleeding disorder

NCT ID NCT05023915

Disease control Sponsor: Shandong University Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding diammonium glycyrrhizinate (a liver-protecting compound) to standard high-dose dexamethasone can improve platelet counts in adults newly diagnosed with immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding. About 106 untreated patients with low platelets or bleeding symptoms will receive either the combination or dexamethasone alone. The main goals are to see if more patients achieve a safe platelet count at 14 days and maintain it for 6 months.

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 106 people

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

Started

Aug 2021

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 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: * Meet the diagnostic criteria for immune thrombocytopenia; * Untreated hospitalized patients or patients from the clinic, may be male or female, between the ages of 18\~ 80 years; * To show a platelet count \<30 \* 10\^9/L, or with bleeding manifestations, or both; * Willing and able to sign written informed consent * ITP patients with hepatitis virus infection or ITP patients with abnormal liver function at the time of enrollment, i.e., ITP patients with indications for diammonium glycyrrhizinate enteric-coated capsule, should be separately stratified. Exclusion Criteria: * secondary thrombocytopenia; * severe immune-deficiency; * active or previous malignancy; * HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess); * pregnancy or lactation; * diabetes; * hypertension; * cardiovascular diseases; * severe kidney function impairment; * psychosis; * osteoporosis; * inflammatory bowel disease or gastric disease; * arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment; * an organ or haematopoietic stem-cell transplantation; * neutrophil count of less than 1500 cells per mm³; * glycosylated haemoglobin less than 8%; * partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN); •clinical electrocardiogram changes; * history of primary immunodeficiency; * neoplastic disease within the past 5 years; * corrected QT interval greater than 450 ms for men and greater than 470 ms for women; * substance misuse within the previous 12 months; * people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.

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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

Contacts and locations

Locations

  • Qilu hospital (Qingdao), Shandong University

    Qingdao, Shandong, 266000, China

  • Qilu hospital, Shandong University

    Jinan, Shandong, 250000, China

More trials for these conditions

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