New combo aims to boost platelets in stubborn ITP
NCT ID NCT04518475
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding rituximab to eltrombopag works better than eltrombopag alone for adults with immune thrombocytopenia (ITP) whose platelet counts stay low despite prior treatments. About 224 participants will receive either the combo or eltrombopag alone, and researchers will track platelet counts over 24 weeks. The goal is to find a safer, more effective way to control this 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
- eltrombopag and rituximab
- What this could lead to
- If successful, this combination could offer a more effective way to raise platelet counts and reduce bleeding risk in adults with hard-to-treat ITP.
- What could go wrong
- This is a phase 4 trial, but the combination may not work better than eltrombopag alone and could increase side effects like infections or liver issues. Results may not apply to all ITP patients.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 224 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2020
- Expected to finish
-
Aug 2030
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 60 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 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. Signed written informed consent 2. Age from 18 to 60 years old 3. Diagnosed with ITP and have a platelet count of \<30 ×10\^9/L on Day 1 (or within 48 hours prior to dosing on Day 1). 4. Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy. 5. Subjects treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completed prior to randomization, or must not be increasing a dose after enrollment. 6. No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) \>450msec or QTc \>480 for patients with a Bundle Branch Block. 7. No pre-existing infection within the last 1 months(including but not limited to pulmonary infection) 8. Laboratory tests for coagulation function showed that prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) no exceed normal by more than 20%. No history of clotting disorder, other than ITP. 9. White blood cell count, neutrophil absolute value, hemoglobin, within the reference range, with the following exceptions: * Hemoglobin: females and males 10.0 g/dl are eligible for inclusion, * Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion 10. The following blood chemistry test result no exceed normal by more than 20%:alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine,serum albumin must not be below the lower limit of normal (LLN) by more than 10%. 11. Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception throughout the study. 12. Subjects fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned. Exclusion Criteria: 1. Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome. 2. Pregnant or lactating women; 3. Subjects is currently receiving treatment with another study medication. 4. Any laboratory or clinical evidence for HIV infection. 5. Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test shows positive serology for Hepatitis C or Hepatitis B (HB). In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. 6. History of platelet aggregation that prevents reliable measurement of platelet counts. 7. Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Primary immune thrombocytopenia are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITINGTianjin, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World data may reveal which ITP treatments work best
- What Trade-Offs are ITP patients willing to make for better treatment?
- Experimental injection aims to boost platelets in chronic blood disorder
- New combo therapy aims to boost platelets in immune disorder
- New hope for kids with ITP: drug combo aims to control bleeding
- Can a vitamin a drug boost platelets in Hard-to-Treat ITP?