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

This study is not yet open for participant recruitment.
Verified March 2012 by Shandong University
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University
ClinicalTrials.gov Identifier:
NCT01568333
First received: March 29, 2012
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  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:

Drug Information available for: Decitabine
U.S. FDA Resources

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 ]

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 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Decitabine
Decitabine 20mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given at least three cycles.
 Drug: Decitabine
Decitabine 20mg/m2，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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 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
Qilu hospital, Shandong University Not yet recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou         houming@medmail.com.cn    
Principal Investigator: Ming Hou            
Sponsors and Collaborators
Shandong University
Investigators
Principal Investigator: Ming Hou Qilu hospital, Shandong University
  More Information

Publications:

Responsible Party: Ming Hou, Ph.D; MD, Shandong University
ClinicalTrials.gov Identifier: NCT01568333     History of Changes
Other Study ID Numbers: ITP-005
Study First Received: March 29, 2012
Last Updated: March 30, 2012
Health Authority: China: Ethics Committee

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 May 16, 2013