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

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: Completed
• Conditions: Previously Treated Primary Immune Thrombocytopenia
• Intervention / Treatment: Drug: rhTPO; Drug: Eltrombopag

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: Interventional
• Enrollment (Actual): 157
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation	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

Outcome Measure	Measure Description	Time Frame
Early response	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	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	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	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	Total duration of time a subject had platelet count ≥50x10^9/L during treatment	in 6 weeks treatment
4 months response	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	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	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	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	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

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China
• Collaborators: 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: Principal Investigator: Lei Zhang, MD, Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): July 16, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Eltrombopag; rhTPO; Primary Immune Thrombocytopenia; Pre-treated
• Additional Relevant MeSH Terms: Cytopenia; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Skin Manifestations; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
• Other Study ID 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