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

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

Interventions

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.

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.

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Shaanxi Provincial People's Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• North China University of Science and Technology

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Second Hospital of Shanxi Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Shenyang Sunshine Pharmaceutical Co., LTD.

  collaborator INDUSTRY

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Kashgar 1st People's Hospital

  collaborator OTHER

• Xi'an Central Hospital

  collaborator OTHER

• Beijing Public Health Foundation

  collaborator UNKNOWN

• Yuyao People's Hospital

  collaborator OTHER

• Institute of Hematology & Blood Diseases Hospital, China

  lead OTHER

Principal Investigators

• Lei Zhang, MD · Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-22

Primary Completion

2024-02-28

Completion

2024-07-16

Countries

• China

Study Locations