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NCT Number: NCT05583838

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

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

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Key information

Conditions

Previously Treated Primary Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

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About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rhTPO

Drug

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

eltrombopag

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. Incidence of adverse events

    Time frame: from study start date to the end of follow-up, up to 6 months

    treatment-related adverse events.

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Collaborators

  • Beijing Public Health Foundation
  • First Affiliated Hospital of Xinjiang Medical University
  • Henan Cancer Hospital
  • Kashgar 1st People's Hospital
  • North China University of Science and Technology
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Second Affiliated Hospital of Guangzhou Medical University
  • Second Hospital of Shanxi Medical University
  • Shaanxi Provincial People's Hospital
  • Shenyang Sunshine Pharmaceutical Co., LTD.
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The Second Affiliated Hospital of Dalian Medical University
  • The Second Affiliated Hospital of Harbin Medical University
  • The Second Affiliated Hospital of Kunming Medical University
  • The Second Hospital of Hebei Medical University
  • Xi'an Central Hospital
  • Xijing Hospital
  • Yuyao People's Hospital

Registry information

Official study title

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

Acronym: TE-ITP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2022
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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