A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts (TE-ITP)

April 22, 2025 updated by: Institute of Hematology & Blood Diseases Hospital, China

Comparing the Efficacy and Safety of Optimized rhTPO Treatment Versus Eltrombopag Treatment in Previously Treated Primary Immune Thrombocytopenia Patients: A Multicenter Randomized Open-label Trial

TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A multicenter randomized open-label trial to compare the efficacy and safety of an optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia. Total treatment duration is 6 weeks, the primary endpoint is "median time to achieve platelet count ≥50x10^9/L during 6 weeks observation".

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530007
        • The Second Affiliated Hospital of Guangxi Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University
    • Heibei
      • Tangshan, Heibei, China, 063000
        • North China University of Science and Technology Affiliated Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • The Second Affiliated Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010107
        • The Affiliated Hospital of Inner Mongolia Medical University
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • The Second Hospital of Dalian Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi Provincial People's Hospital
      • Xi'an, Shaanxi, China, 710032
        • Xi'an Central Hospital
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital of the Fourth Military Medical University
    • Tianjin
      • Tianjin, Tianjin, China, 300211
        • The Second Hospital of Tianjin Medical University
      • Tianjin, Tianjin, China, 300020
        • Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
    • Xinjiang
      • Kashgar, Xinjiang, China, 844000
        • Kashgar District 1st People's Hospital
      • Ürümqi, Xinjiang, China, 830001
        • People's Hospital of Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang, China, 830011
        • The First Affiliated Hospital of Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • The Second Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Yuyao, Zhejiang, China, 315400
        • Yuyao People's Hospital of Zhejiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject is ≥18 years old.
  • Disease duration is ≥3 months, diagnosed and treated as ITP prior to screening.
  • Baseline platelet count <30×10^9/L.
  • Subjects treated with maintenance corticosteroids or immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
  • Informed consent has been signed.

Exclusion Criteria:

  • Classified as refractory ITP.
  • Subjects with any prior history of arterial or venous thrombosis, or thrombophilia in recent 1 year.
  • Subjects who have previously received any platelet increasing drug such as rhTPO, thrombopoietin receptor agonist(TPO-RA), etc. within 30 days.
  • Subjects who are known nonresponders to rhTPO or TPO-RA therapy.
  • Subjects with positive hepatitis C virus antibody or human immunodeficiency virus(HIV) antibody, positive HBsAg and serum levels of hepatitis B virus (HBV) DNA >1000cps/ml.
  • TBil or Scr> 1.5 x upper limit of normal (ULN), ALT or AST> 3.0 x ULN in recently 2 weeks.
  • Subjects with any prior history of tumor.
  • Female subjects who are nursing or pregnant.
  • Any situation that investigate consider not suitable for pts to join the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Optimized rhTPO treatment
The study in a 2:1 randomization ratio (117 subjects to rhTPO group).
Drug: rhTPO
initial therapy: rhTPO s.c, 300 or 600U/kg daily based on baseline platelet count; maintenance therapy: rhTPO s.c, 300 ~ 600U/kg every other day depends on platelet count.
Other Names:
  • Recombinant human thrombopoietin
  • TPIAO
Active Comparator: Eltrombopag treatment
The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).
Drug: Eltrombopag
initial therapy: Eltrombopag oral, 25 or 50mg daily based on baseline platelet count; maintenance therapy: Eltrombopag oral, 25 ~ 75mg daily or every other day depends on platelet count.
Other Names:
  • Eltrombopag olamine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation
Time Frame: in 6 weeks treatment
Time from the start of treatment to the first time of achieving a platelet count ≥50x10^9/L without salvage therapy during the first 6 weeks.
in 6 weeks treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early response
Time Frame: after 1 week treatment
Early response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 week.
after 1 week treatment
Initial response
Time Frame: after 1 month treatment
Initial response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 month.
after 1 month treatment
6 weeks response
Time Frame: after 6 weeks treatment
6 weeks response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 weeks.
after 6 weeks treatment
Durable response
Time Frame: after 6 months treatment
Durable response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 months.
after 6 months treatment
The duration time with platelet count ≥50x10^9/L
Time Frame: in 6 weeks treatment
Total duration of time a subject had platelet count ≥50x10^9/L during treatment
in 6 weeks treatment
4 months response
Time Frame: after 4 months treatment
4 months response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 3 months.
after 4 months treatment
Time to treatment failure
Time Frame: in 6 weeks treatment

Treatment failure is defined as:

  • a platelet count < 30 x 10^9/L for 4 consecutive weeks at the highest dose and schedule ; or,
  • a major bleeding event; or,
  • a change in therapy due to an intolerable side effect or bleeding symptoms (including a minor bleeding event).
in 6 weeks treatment
Incidence of adverse events
Time Frame: from study start date to the end of follow-up, up to 6 months
treatment-related adverse events.
from study start date to the end of follow-up, up to 6 months
Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0
Time Frame: from study start date to the end of follow-up, up to 6 months
Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0
from study start date to the end of follow-up, up to 6 months
Number of subjects who develop anti-rhTPO antibodies
Time Frame: from study start date to the end of follow-up, up to 6 months
Number of subjects who develop anti-rhTPO antibodies
from study start date to the end of follow-up, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Hematology & Blood Diseases Hospital, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xijing Hospital
Xi'an Central Hospital
The Second Hospital of Hebei Medical University
Henan Cancer Hospital
Shaanxi Provincial People's Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
The Second Affiliated Hospital of Harbin Medical University
Second Affiliated Hospital of Guangzhou Medical University
First Affiliated Hospital of Xinjiang Medical University
The Affiliated Hospital of Inner Mongolia Medical University
Shenyang Sunshine Pharmaceutical Co., LTD.
Second Hospital of Shanxi Medical University
The Second Affiliated Hospital of Dalian Medical University
The Second Affiliated Hospital of Kunming Medical University
Kashgar 1st People's Hospital
North China University of Science and Technology Affiliated Hospital
Yuyao People's Hospital
Beijing Public Health Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lei Zhang, MD, Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT2022037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.

IPD Sharing Time Frame

From 12 months 36 months after study completion.

IPD Sharing Access Criteria

Upon request to PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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