We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified March 2016 by Ming Hou, Shandong University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01568333
First Posted: April 2, 2012
Last Update Posted: July 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Qingdao University
Shandong Provincial Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University
  Purpose
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: 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

Resource links provided by NLM:


Further study details as provided by Ming Hou, Shandong University:

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

Secondary Outcome Measures:
  • Bleeding score [ Time Frame: every 3 days after the treatment ]

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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


Contacts
Contact: Ming Hou houming@medmail.com.cn

Locations
China, Shandong
Shandong University Qilu hospital Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou       houming@medmail.com.cn   
Principal Investigator: Ming Hou         
Sponsors and Collaborators
Shandong University
Qingdao University
Shandong Provincial Hospital
Investigators
Principal Investigator: Ming Hou Qilu hospital, Shandong University
  More Information

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 Submitted: March 29, 2012
First Posted: April 2, 2012
Last Update Posted: July 27, 2016
Last Verified: March 2016

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