NCT03515096

Brief Summary

The primary objective is to compare the efficacy of eltrombopag vs rhTPO in complete response in patients after HSCT in China. This is a post-marketing, interventional, single-center, double-arm, prospective, open-label, non-inferior, randomized controlled study in adult patients with hematopoietic stem cell transplantation in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given eltrombopag or rhTPO under the conditions of informed consent and frequent monitoring according to the clinical guideline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

April 22, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 27, 2022

Status Verified

June 1, 2022

Enrollment Period

3.1 years

First QC Date

April 22, 2018

Last Update Submit

July 26, 2022

Conditions

EltrombopagHematopoietic Stem Cell TransplantationThrombocytopenia

Keywords

rhTPOHSCTThrombopoietin

Outcome Measures

Primary Outcomes (1)

  • The cumulative numbers of platelet engraftment (platelet recovery to ≥20 X 109/L for seven consecutive days without transfusion) on day 60 after transplantation

    From the start of study treatment (Day 1) to day 60

Secondary Outcomes (4)

  • Number of Participants (Responders) Achieving a Platelet Count >=30×10^9/L On Day 21 After HSCT

    From the start of study treatment (Day 1) to days 21

  • Number of Participants (Responders) Achieving a Platelet Count >=100×10^9/L On Day 21 After HSCT

    From the start of study treatment (Day 1) to days 21

  • Number of Participants With Bleeding events as Assessed Using the predefined bleeding scoring system.

    From the start of study treatment (Day 1) to days 90

  • Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

    From the start of study treatment (Day 1) to days 90

Study Arms (2)

Eltrombopag

EXPERIMENTAL

Thrombopoietin- receptor (TPO-R) agonist

Drug: Eltrombopag

rhTPO

PLACEBO COMPARATOR

Recombinant human thrombopoietin (rhTPO)

Drug: rhTPO

Interventions

EltrombopagDRUG

Eltrombopag 50 mg; po; from day 1 to platelet is completely effective recovered after HSCT.

Also known as: Promacta, Revolade
Eltrombopag
rhTPODRUG

rhTPO 15000 u; subcutaneously injection; from day 1 to platelet is completely effective recovered after HSCT.

Also known as: no other name
rhTPO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18;
  • Patients who have undergone hematopoietic stem cell transplantation (HSCT);
  • Patients who don't take any drug including Eltrombopag and rhTPO before hematopoietic stem cell transplantation (HSCT);
  • Patients receiving either an autologous (Auto) or allogeneic (Allo) stem cell transplantation from a sibling,related donor, or matched unrelated donor are included;
  • Agree to sign informed consent

You may not qualify if:

  • Patients with thrombocytopenia causes by other reasons, such as drugs, cytomegalovirus or infection;
  • Patients who had greater risk of thromboembolic disease within six months;
  • Patients with a history of heart disease;
  • Patients with severe organ dysfunction;
  • Patients with other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

Location

Related Publications (1)

  • Wen B, Zhang X, Chen S, Fan J, Yang S, Cai Y, Wang P, Zhang Q, Gu Q, Du X. Oral eltrombopag versus subcutaneous recombinant human thrombopoietin for promoting platelet engraftment after allogeneic stem cell transplantation: A prospective, non-inferiority, randomized controlled trial. Hematol Oncol. 2022 Oct;40(4):777-786. doi: 10.1002/hon.3017. Epub 2022 May 18.

    PMID: 35554955DERIVED

MeSH Terms

Conditions

ThrombocytopeniaJacobs syndrome

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • XIN DU, MD

    Second People's Hospital of Shenzhen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2018

First Posted

May 3, 2018

Study Start

July 1, 2018

Primary Completion

August 2, 2021

Study Completion

July 1, 2022

Last Updated

July 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)