A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts
NCT ID: NCT05583838
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
157 participants
INTERVENTIONAL
2022-11-22
2024-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Optimized rhTPO treatment
The study in a 2:1 randomization ratio (117 subjects to rhTPO group).
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.
Eltrombopag treatment
The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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The Second Hospital of Hebei Medical University
OTHER
Xijing Hospital
OTHER
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
The Second Affiliated Hospital of Kunming Medical University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Shaanxi Provincial People's Hospital
OTHER
Henan Cancer Hospital
OTHER_GOV
North China University of Science and Technology
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
Second Hospital of Shanxi Medical University
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Shenyang Sunshine Pharmaceutical Co., LTD.
INDUSTRY
First Affiliated Hospital of Xinjiang Medical University
OTHER
People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
Kashgar 1st People's Hospital
OTHER
Xi'an Central Hospital
OTHER
Beijing Public Health Foundation
UNKNOWN
Yuyao People's Hospital
OTHER
Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Principal Investigators
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Lei Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
Locations
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The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
the Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Heibei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Xi'an Central Hospital
Xi'an, Shaanxi, China
Xijing Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
Tianjin, Tianjin Municipality, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Kashgar District 1st People's Hospital
Kashgar, Xinjiang, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
The first affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Yuyao People's Hospital of Zhejiang Province
Yuyao, Zhejiang, China
Countries
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References
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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.
Other Identifiers
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IIT2022037
Identifier Type: -
Identifier Source: org_study_id
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