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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Shandong University
Qingdao University
Shandong Provincial Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University Identifier:
First received: March 29, 2012
Last updated: July 26, 2016
Last verified: March 2016
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 Intervention Phase
Immune Thrombocytopenia
Drug: Decitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia

Resource links provided by NLM:

Further study details as provided by Shandong University:

Primary Outcome Measures:
  • Platelet count [ Time Frame: every 3 days after the treatment ] [ Designated as safety issue: Yes ]
  • Megakaryocyte Polyploidy [ Time Frame: 8 days after every treatment cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bleeding score [ Time Frame: every 3 days after the treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
The investigators are undertaking a multicenter, single-arm study of 30 primary ITP adult patients from 5 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). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01568333

Contact: Ming Hou

China, Shandong
Shandong University Qilu hospital Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou   
Principal Investigator: Ming Hou         
Sponsors and Collaborators
Shandong University
Qingdao University
Shandong Provincial Hospital
Principal Investigator: Ming Hou Qilu hospital, Shandong University
  More Information

Responsible Party: Ming Hou, Professor and Director, Shandong University Identifier: NCT01568333     History of Changes
Other Study ID Numbers: ITP-Low-dose Decitabine  81270578 
Study First Received: March 29, 2012
Last Updated: July 26, 2016
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Immune thrombocytopenia

Additional relevant MeSH terms:
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors processed this record on October 21, 2016