NCT03902041

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 3, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 30, 2019

Last Update Submit

April 2, 2019

Conditions

Allogeneic Hematopoietic Stem Cell TransplantationEltrombopag

Outcome Measures

Primary Outcomes (2)

  • The engraftment of platelet

    the day of platelet engraftment

    3 years

  • The levels of platelet

    The levels of platelet at 30 days after transplantation

    3 years

Secondary Outcomes (1)

  • The number of platelet transfusions

    3 years

Other Outcomes (2)

  • The engraftment of white blood cell

    3 years

  • OS

    3 years

Study Arms (2)

Treatment Group

The patients will receive Eltrombopag treatment after transplantation at d1.

Drug: Eltrombopag

Control Group

The patients will not receive Eltrombopag treatment after transplantation.

Interventions

EltrombopagDRUG

The patients will receive Eltrombopag treatment after transplantation

Treatment Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients after allogeneic hematopoietic stem cell transplantation

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heamtology Department, Provincial Hospital Affiliated to Shandong University

Jinan, Shandong, 250021, China

Location

MeSH Terms

Interventions

eltrombopag

Study Officials

  • Xin Wang

    Shandong Provincial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaosheng Fang

CONTACT

15168889703fxsh_1010@126.com

Xin Wang

CONTACT

xinw007@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Hematology Department

Study Record Dates

First Submitted

March 30, 2019

First Posted

April 3, 2019

Study Start

May 1, 2019

Primary Completion

April 30, 2022

Study Completion

October 1, 2022

Last Updated

April 3, 2019

Record last verified: 2019-03

Locations

CN(1)