Double attack on blood disorder: could two drugs beat one for stubborn ITP?
NCT ID NCT07687134
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding telitacicept to eltrombopag works better than eltrombopag alone for adults with immune thrombocytopenia (ITP) that hasn't improved with steroids. ITP is a bleeding disorder where the immune system destroys platelets. The study aims to see if the combination helps more patients maintain safe platelet levels without bleeding for 24 weeks after stopping treatment. Forty participants will be randomly assigned to either the combination or eltrombopag alone for 12 weeks, then followed for another 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eltrombopag and telitacicept
- What this could lead to
- If successful, this combination could offer a more durable remission for people with immune thrombocytopenia who do not respond to steroids.
- What could go wrong
- This is a small, early-phase study with only 40 participants, so results may not apply broadly. The combination may not improve outcomes and could increase side effects like infection or bleeding.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 ≥18 years, regardless of sex. 2. Clinically diagnosed with immune thrombocytopenia for at least 3 months prior to enrollment. Platelet count \<30×10⁹/L within 48 hours before the first dose of study drug. 3. Previous failure (ineffective, unable to maintain response, or relapse) to first-line standard corticosteroid therapy for ITP as recommended by guidelines. 4. Any prior emergency treatment for ITP (e.g., corticosteroids, platelet transfusion, intravenous immunoglobulin) must have been completed at least 2 weeks before the first dose. 5. Patients receiving maintenance corticosteroid therapy must be on a stable dose for at least 2 weeks prior to the first dose; patients receiving immunosuppressants (e.g., azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, etc.) must be on a stable dose for at least 4 weeks prior to the first dose; anti-CD20 antibody therapy must have been completed \>3 months prior. Understand the study procedures and voluntarily provide written informed consent. Exclusion Criteria: 1. Received anti-CD20 antibody therapy within 3 months. 2. Uncontrolled primary disease of vital organs, such as malignant tumors, liver failure, heart failure, renal failure, etc. 3. Positive for HIV. 4. Uncontrolled active viral or bacterial infections, including positive for hepatitis B, hepatitis C, cytomegalovirus, Epstein-Barr virus, or syphilis. 5. Extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc. 6. Currently have cardiac disease requiring treatment, arrhythmia, or hypertension poorly controlled as judged by the investigator. 7. Patients with thrombotic diseases such as pulmonary embolism, thrombosis, atherosclerosis, etc. 8. Patients with mental disorders who are unable to give informed consent or undergo study procedures and follow-up normally. 9. Patients whose toxic symptoms from prior treatment before enrollment have not yet resolved. 10. Other serious diseases that may limit the patient's participation in this study (e.g., poorly controlled diabetes; severe cardiac insufficiency; myocardial infarction, unstable arrhythmia, or unstable angina within the past 6 months; gastric ulcer; active autoimmune disease, etc.). 11. Pregnant women, suspected pregnancy (positive urinary human chorionic gonadotropin pregnancy test at screening), or lactating patients.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Ethics Committee of Blood disease hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
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Other studies related to the condition(s) this trial covers.
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