Low-dose Decitabine Versus Recombinant Human Thrombopoietin for the Treatment of Refractory Immune Thrombocytopenia

This study is currently recruiting participants.
Verified May 2013 by Shandong University
Sponsor:
Collaborators:
Soochow University
Shandong Provincial Hospital
China Medical University, China
Information provided by (Responsible Party):
Ming Hou, Shandong University
ClinicalTrials.gov Identifier:
NCT01568333
First received: March 29, 2012
Last updated: June 12, 2013
Last verified: May 2013
  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
Drug: rhTPO
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low-dose Decitabine Versus Recombinant Human Thrombopoietin for the Treatment of Refractory 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: 60
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Decitabine
Decitabine 5mg,ivdrip,qd x 3d, every four weeks for one cycle. It will be given at least three cycles.
Drug: Decitabine
Decitabine 5mg,ivdrip,qd x 3d, every four weeks for one cycle. It will be given at least three cycles.
Active Comparator: rhTPO
TPO 300U/Kg ,subcutaneous injection,qd x 7-14d。Within 14 days,if platelet count≥50×109/L,TPO dosage should be reduced;if platelet count≥150×109/L,TPO treatment should be stopped.
Drug: rhTPO
TPO 300U/Kg ,subcutaneous injection,qd x 7-14d。Within 14 days,if platelet count≥50×109/L,TPO dosage should be reduced;if platelet count≥150×109/L,TPO treatment should be stopped.

Detailed Description:

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 60 primary ITP adult patients from 6 medical centers in China. One part of the participants are randomly selected to receive low-dose of decitabine treatment (given intravenously at a dose of 5 mg daily for 3 days), the others are selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of decitabine therapy compared to conventional recombinant human thrombopoietin therapy for the treatment of adults with refractory ITP.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • failure to achieve at least Response or loss of Response after splenectomy
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Soochow University
Shandong Provincial Hospital
China Medical University, China
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-Decitabine versus TPO, 81270578
Study First Received: March 29, 2012
Last Updated: June 12, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Decitabine
rhTPO
Immune thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014