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

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ClinicalTrials.gov Identifier: NCT01568333
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
Qingdao University
Shandong Provincial Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Decitabine Phase 2

Detailed Description:
The investigators are undertaking a multicenter, single-arm study of primary ITP adult patients from 9 medical centers in China. All the participants are selected to receive low-dose of decitabine treatment (given intravenously at a dose of 3.5mg/m2 for 3 days per cycle for 3 cycles). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia
Actual Study Start Date : August 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : August 2018


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




Primary Outcome Measures :
  1. Platelet count [ Time Frame: the third month after the first dose of decitabine ]
    plate level at the third month after the first dose of decitabine


Secondary Outcome Measures :
  1. Bleeding score [ Time Frame: at enrollment and the third month after the first dose of decitabine ]
    the assessment of bleeding scores at enrollment and at the third month after the first dose of decitabine



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients with the diagnosis of ITP according to the International Working Group (IWG) guidelines
  • failure to splenectomy or at least four standard ITP-specific treatments, but not necessarily undergone splenectomye
  • baseline peripheral platelet count less than 30,000/uL or the presence of bleeding symptoms
  • 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

Exclusion Criteria:

  • secondary ITP
  • pregnancy
  • hypertension
  • cardiovascular disease
  • diabetes
  • liver and kidney function impairment
  • HCV, HIV, HBsAg seropositive status
  • patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568333


Locations
China, Shandong
Shandong University Qilu hospital
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Qingdao University
Shandong Provincial Hospital
Investigators
Principal Investigator: Ming Hou Qilu hospital, Shandong University

Publications:
Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT01568333     History of Changes
Other Study ID Numbers: ITP-Low-dose Decitabine
81270578 ( Other Grant/Funding Number: Natural Science Foundation of China )
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Keywords provided by Ming Hou, Shandong University:
Decitabine
Immune thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Decitabine
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors