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New combo therapy shows promise for Steroid-Resistant ITP

NCT ID NCT05438875

Disease control Sponsor: Peking University People's Hospital 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This completed phase 3 trial tested whether adding all-trans retinoic acid (ATRA) to eltrombopag works better than eltrombopag alone for adults with immune thrombocytopenia (ITP) that did not respond to steroids. The study enrolled 96 participants and measured sustained platelet count improvement at 18 months. The goal is to find a more effective treatment option for this chronic bleeding disorder.

What this could mean

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

Active substance
all-trans retinoic acid (ATRA) and eltrombopag
What this could lead to
If successful, this combination could offer a more effective treatment option for people with immune thrombocytopenia (ITP) that does not respond to steroids, helping maintain safe platelet levels.
What could go wrong
This is a relatively small phase 3 trial (96 participants), and results may not apply to all ITP patients. The combination may cause side effects, and long-term benefits are not guaranteed.

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

96 people

The number who actually took part.

Started

Oct 2022

Finished

Nov 2024

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 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\. Isolated thrombocytopenia (platelet count \<30 × 109/L); 2. age \> 18 years; 3. normal white blood cells and red blood cells on bone marrow examination; 4. increased number of megakaryocytes (bone marrow examination was performed in all patients except for myelofibrosis or other conditions that can cause thrombocytopenia disease); 5. the spleen was normal in size; 6. Eastern Cooperative Oncology Group status score (ECOG score) ≤ 2; 7. ineffective or relapsed after at least 1 course of full-dose full-course hormone therapy; 8. Failure of prior ITP therapy (eg, hormones, splenectomy, and cyclosporine) and at least 4 weeks from enrollment. Exclusion Criteria: * 1\. Secondary ITP such as drug-related thrombocytopenia; 2. thrombocytopenia due to viral infection (HIV, hepatitis B virus, or hepatitis C virus); 3. severe cardiac, renal, hepatic, or respiratory insufficiency; 4. severe immunodeficiency; 5. pregnancy or lactation; 6. myelodysplasia or Myelofibrosis; 7. history of malignancy; 8. ongoing immunosuppressive therapy for other diseases; 9. patients previously treated with eltrombopag were excluded from this study.

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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.

Purpura, thrombocytopenic, idiopathic

Contacts and locations

Locations

  • Beijing Tongren hospital

    Beijing, Beijing Municipality, China

  • Department of Hematology, Beijing Friendship Hospital, Capital Medical University

    Beijing, China

  • Department of Hematology, Beijing Hospital

    Beijing, China

  • Department of Hematology, Senior Department of Hematology, the Fifth Medical Center of PLA General Hospital

    Beijing, China

  • Peking University Insititute of Hematology, Peking University People's Hospital

    Beijing, Beijing Municipality, 100010, China

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