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Immune Thrombocytopenia | A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia

Immune Thrombocytopenia research study

What is the primary objective of this study?

Decitabine has been reported to have a clinically significant, often long lasting effect on the platelet count in myelodysplastic syndromes(MDS). It is also reported that decitabine could increase platelet counts by enhancing megakaryocyte maturation and platelet release. Immune thrombocytopenia(ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of decitabine in the treatment of ITP.

Who is eligible to participate?

Inclusion Criteria: - failure to achieve at least Response - need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. Need of on-demand or adjunctive therapy alone does not qualify the patient as refractory - primary ITP confirmed by excluding other supervened causes of thrombocytopenia Exclusion Criteria: - pregnancy - hypertension - cardiovascular disease - diabetes - liver and kidney function impairment - HCV, HIV, HBsAg seropositive status - patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Immune Thrombocytopenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DecitabineDecitabine 3.5mg/m2,ivdrip,qd x 3d, every four weeks for one cycle. It will be given three cycles.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

DecitabineDecitabine 3.5mg/m2,ivdrip,qd x 3d, every four weeks for one cycle. It will be given three cycles.

Study Status

Recruiting

Start Date: June 2015

Completed Date: December 2017

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Platelet count

Secondary Outcome: Bleeding score

Study sponsors, principal investigator, and references

Principal Investigator: Ming Hou

Lead Sponsor: Shandong University

Collaborator: Qingdao University

More information:https://clinicaltrials.gov/show/NCT01568333

van den Bosch J, Lübbert M, Verhoef G, Wijermans PW. The effects of 5-aza-2'-deoxycytidine (Decitabine) on the platelet count in patients with intermediate and high-risk myelodysplastic syndromes. Leuk Res. 2004 Aug;28(8):785-90.

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