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

The Prospective Randomized Controlled Clinical Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic Hematopoietic Stem Cell Transplantation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03902041
Enrollment
160
Registered
2019-04-03
Start date
2019-05-01
Completion date
2022-10-01
Last updated
2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation, Eltrombopag

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.

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.

Interventions

DRUGEltrombopag

The patients will receive Eltrombopag treatment after transplantation

Sponsors

Shandong Provincial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The engraftment of platelet3 yearsthe day of platelet engraftment
The levels of platelet3 yearsThe levels of platelet at 30 days after transplantation

Secondary

MeasureTime frameDescription
The number of platelet transfusions3 yearsThe number of platelet units be transfused to the patients before platelet engraftment

Other

MeasureTime frameDescription
The engraftment of white blood cell3 yearsThe day of white blood cell engraftment
OS3 years3years overall survival of the patients

Countries

China

Contacts

Primary ContactXiaosheng Fang
fxsh_1010@126.com15168889703
Backup ContactXin Wang
xinw007@126.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026