Can a Low-Dose booster keep platelets up in ITP?
NCT ID NCT03010202
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers test whether giving low-dose rituximab after an initial treatment can make the response last longer in adults with immune thrombocytopenia (ITP), a condition where the immune system attacks platelets. The trial enrolls adults whose ITP has not responded well to steroids. Participants first receive rituximab with or without dexamethasone, and those who respond are then randomly assigned to receive either low-dose rituximab or a placebo. The goal is to see if maintenance rituximab keeps platelet counts stable and delays relapse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rituximab, a drug that targets immune cells, with or without dexamethasone
- What this could lead to
- If it works, low-dose rituximab maintenance could help people with immune thrombocytopenia keep their platelet counts up for longer without needing other treatments.
- What could go wrong
- Rituximab can weaken the immune system and cause infusion reactions. The trial may show that maintenance does not extend responses, or that benefits do not outweigh the risks.
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
-
136 people
The number who actually took part.
- Started
-
Jan 2017
- Finished
-
Dec 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 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 First randomization (Induction phase): 1. Male or female aged ≥18 years. 2. Diagnosis of primary ITP of less than one year duration having a platelet count of ≤ 30 x109/L measured within 4 weeks prior to inclusion with failure to achieve initial response or relapse either after one cycle of dexamethasone (40 mg daily for 4 days) or 4 weeks with any other steroid (prednisone or prednisolone). Platelet count between 31 to 50 x109/L is accepted if higher platelet count is required due to concomitant antiplatelet therapy or bleeding. 3. Scheduled intravenous treatment of rituximab. 4. Signed and dated written informed consent. 5. Females of child-bearing potential accepting to follow effective contraceptive methods for at least 12 months following the last administration of rituximab or placebo. Inclusion criteria second randomization (maintenance phase): 1. Completion of the induction phase (phase 1) of the study. 2. Sustained response at the end of phase 1. 3. Randomization within 4 weeks after the completion of phase 1, i.e. between week 24 and 28. Exclusion Criteria first randomization (Induction phase): 1. Previous treatment for ITP with: rituximab, other immune suppressants (including mycophenolate mofetil, aziothioprin, cyclosporine), chemotherapy or splenectomy. 2. Pregnancy or lactation. 3. Known active gastro-duodenal ulcer. 4. Secondary ITP: ITP associated with lymphoma, chronic lymphocytic leukemia, autoimmune disorders such as, common variable immune deficiency, human immunodeficiency virus, or hepatitis C or thrombocytopenia associated with myeloid dysplasia. 5. Concomitant autoimmune hemolytic anemia. 6. History of any major cardiovascular event within the 6 months prior to randomization, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, or New York Heart Association Class III or IV heart failure. 7. Active hepatitis B virus or patients with positive HBsAG or HBcAB. 8. Patients with active severe infection, including systemic mycotic infections or a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection. 9. Known allergy and/or sensitivity or contraindication to rituximab or dexamethasone or any of the ingredients. 10. Patients in a severely immune compromised state. 11. Known contraindication to a treatment with any proton-pump inhibitor. 12. Active malignancy or history of malignant disease during the last 2 years except cured skin cancer. 13. Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent. Exclusion criteria second randomization (maintenance phase) 14. Severe allergic reaction or serum sickness due to rituximab in phase 1 of the study. 15\. Pregnancy. 16. Treatment with rescue medication after week 18. 17. Patients refusing to continue in the study (withdrawal of consent). 18. Splenectomy performed for any cause. \-
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Purpura, thrombocytopenic, idiopathic 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.
Contacts and locations
Locations
-
Ostfold Hospital Trust
Sarpsborg, 1714, Norway
More trials for these conditions
Other studies related to the condition(s) this trial covers.