This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance
therapy may prolong the the effect of Rituximab in immune thrombocytopenia.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT03010202
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
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.
All locations for NCT03010202
Ostfold Hospital Trust
Sarpsborg, Norway, 1714
Put me in touch!
View full eligibility
Tris trial is registered with FDA with number: NCT03010202. The sponsor of the trial is Ostfold Hospital Trust and it is looking for 100 volunteers for the current phase.
Official trial title: Prolonging the Response by Low-dose Rituximab Maintenance Therapy in Immune Thrombocytopenia: a Randomized Placebo-controlled Trial - the PROLONG Trial
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