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

NCT ID: NCT03902041

Last Updated: 2019-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2022-10-01

Brief Summary

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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

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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.

Conditions

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Allogeneic Hematopoietic Stem Cell Transplantation Eltrombopag

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment Group

The patients will receive Eltrombopag treatment after transplantation at d1.

Eltrombopag

Intervention Type DRUG

The patients will receive Eltrombopag treatment after transplantation

Control Group

The patients will not receive Eltrombopag treatment after transplantation.

No interventions assigned to this group

Interventions

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Eltrombopag

The patients will receive Eltrombopag treatment after transplantation

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wang Xin

Director of Hematology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xin Wang

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Hospital

Locations

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Heamtology Department, Provincial Hospital Affiliated to Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Xiaosheng Fang

Role: CONTACT

15168889703

Xin Wang

Role: CONTACT

Facility Contacts

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Xiaosheng Fang

Role: primary

15168889703

Xin Wang

Role: backup

Other Identifiers

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SDPH001

Identifier Type: -

Identifier Source: org_study_id

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