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

NCT05583838 | Completed Phase 4

• 1 other identifier: IIT2022037
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Previously Treated Primary Immune Thrombocytopenia

Keywords

rhTPO; Eltrombopag; Pre-treated; Primary Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Early response

  after 1 week treatment

• Initial response

  after 1 month treatment

• 6 weeks response

  after 6 weeks treatment

• 4 months response

  after 4 months treatment

• Durable response

  after 6 months treatment

Study Arms (2)

Optimized rhTPO treatment

EXPERIMENTAL

The study in a 2:1 randomization ratio (117 subjects to rhTPO group).

Drug: rhTPO

Eltrombopag treatment

ACTIVE COMPARATOR

The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).

Drug: Eltrombopag

Interventions

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.

Also known as: Recombinant human thrombopoietin, TPIAO

Optimized rhTPO treatment

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.

Also known as: Eltrombopag olamine

Eltrombopag treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (17)

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530007, China

Location

the Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, 050000, China

Location

North China University of Science and Technology Affiliated Hospital

Tangshan, Heibei, 063000, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010107, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

Location

Xi'an Central Hospital

Xi'an, Shaanxi, 710032, China

Location

Xijing Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

Location

Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC

Tianjin, Tianjin Municipality, 300020, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

Kashgar District 1st People's Hospital

Kashgar, Xinjiang, 844000, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

Location

The first affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650101, China

Location

Yuyao People's Hospital of Zhejiang Province

Yuyao, Zhejiang, 315400, China

Location

Related Publications (1)

• Chen Y, Sun T, Gao D, Wang W, Zhou Z, Gao G, Wang Y, Zhou H, Song Y, Lai Y, Yan Z, Yan J, Bai J, Zhang L. Dose-optimised recombinant human thrombopoietin versus eltrombopag in patients with immune thrombocytopenia: a multicenter, randomised controlled trial (The TE-ITP Study). EClinicalMedicine. 2025 Aug 21;87:103459. doi: 10.1016/j.eclinm.2025.103459. eCollection 2025 Sep.

  PMID: 40896456 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Thrombopoietin; eltrombopag

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Lei Zhang, MD

  Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 18, 2022
• Study Start: November 22, 2022
• Primary Completion: February 28, 2024
• Study Completion: July 16, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From 12 months 36 months after study completion.
• Access Criteria: Upon request to PI.

Locations

CN (17)