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The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT

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.
 
ClinicalTrials.gov Identifier: NCT03902041
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Wang Xin, Shandong Provincial Hospital

Brief Summary:
This study evaluates the addition of Eltrombopag after Hematopoietic stem cell transplantation (HSCT) to improve the engraftment of hematopoietic stem cell. Half of the participants will receive Eltrombopag,while the other will not receive the Eltrombopag.

Condition or disease Intervention/treatment
Allogeneic Hematopoietic Stem Cell Transplantation Eltrombopag Drug: Eltrombopag

Detailed Description:
With the progress of transplantation technology,allogeneic hematopoietic stem cell transplantation is becoming an important treatment for hematological diseases and the long-term survival of patients is gradually improved. However, thrombocytopenia after transplantation has always been an important complication. Studies have shown that about 20% patients had different degrees of thrombocytopenia. Eltrombopag could promote hematopoietic stem cell proliferation and differentiation in vitro studies. It has also been widely used in the treatment of immune thrombocytopenia (ITP) and aplastic anemia(AA) and increased platelet levels in such diseases. Eltrombopag is also used to treat poor platelet engraftment after transplantation and the effective rate is about 60%-80%. Therefore, the application of Eltrombopag at early time after transplantation might promote platelet engraftment and reduce platelet transfusions.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Prospective Randomized Controlled Clinical Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic Hematopoietic Stem Cell Transplantation
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Eltrombopag

Group/Cohort Intervention/treatment
Treatment Group
The patients will receive Eltrombopag treatment after transplantation at d1.
Drug: Eltrombopag
The patients will receive Eltrombopag treatment after transplantation

Control Group
The patients will not receive Eltrombopag treatment after transplantation.



Primary Outcome Measures :
  1. The engraftment of platelet [ Time Frame: 3 years ]
    the day of platelet engraftment

  2. The levels of platelet [ Time Frame: 3 years ]
    The levels of platelet at 30 days after transplantation


Secondary Outcome Measures :
  1. The number of platelet transfusions [ Time Frame: 3 years ]
    The number of platelet units be transfused to the patients before platelet engraftment


Other Outcome Measures:
  1. The engraftment of white blood cell [ Time Frame: 3 years ]
    The day of white blood cell engraftment

  2. OS [ Time Frame: 3 years ]
    3years overall survival of the patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients after allogeneic hematopoietic stem cell transplantation
Criteria

Inclusion Criteria:

  1. Patients with definite diagnosis of hematological diseases, more than 30 kg, age18-60 years, gender and race are not limited;
  2. Acceptance of allogeneic hematopoietic stem cell transplantation;
  3. Voluntary acceptance of the study

Exclusion Criteria:

  1. Patients with severe organ dysfunction or disease;
  2. Patients who cannot tolerate oral Eltrombopag therapy;
  3. Patients who refuse all-HSCT and Eltrombopag treatment;
  4. Patients that investigator believed not suitable for enrollment.

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): NCT03902041


Contacts
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Contact: Xiaosheng Fang 15168889703 fxsh_1010@126.com
Contact: Xin Wang xinw007@126.com

Locations
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China, Shandong
Heamtology Department, Provincial Hospital Affiliated to Shandong University
Jinan, Shandong, China, 250021
Contact: Xiaosheng Fang    15168889703    fxsh_1010@126.com   
Contact: Xin Wang       xinw007@126.com   
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Principal Investigator: Xin Wang Shandong Provincial Hospital
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Responsible Party: Wang Xin, Director of Hematology Department, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT03902041    
Other Study ID Numbers: SDPH001
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No