Prospective Study of Patients With Thrombocytopenia Following HSCT

NCT02487563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2020-05-06

Study results available
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Summary

Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.

Conditions

Interventions

DRUG

Decitabine

Decitabine

DRUG

rhTPO

rhTPO

OTHER

Conventional Treatment

immunoglobulin, glucocorticoid etc

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Ruijin Hospital

    collaborator OTHER
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER
  • Qilu Hospital of Shandong University

    collaborator OTHER
  • Children's Hospital of Soochow University

    collaborator OTHER
  • Fujian Medical University Union Hospital

    collaborator OTHER
  • Hebei Yanda Ludaopei Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Depei Wu, PhD,MD · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-04-12
Completion
2019-04-12

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02487563 on ClinicalTrials.gov