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

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ClinicalTrials.gov Identifier: NCT05583838

Recruitment Status : Recruiting

First Posted : October 18, 2022

Last Update Posted : January 26, 2023

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

The Second Hospital of Hebei Medical University

Xijing Hospital

The Affiliated Hospital of Inner Mongolia Medical University

The Second Affiliated Hospital of Kunming Medical University

Second Affiliated Hospital of Guangzhou Medical University

Shaanxi Provincial People's Hospital

Henan Cancer Hospital

North China University of Science and Technology Affiliated Hospital

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

The Second Affiliated Hospital of Dalian Medical University

Second Hospital of Shanxi Medical University

The Second Affiliated Hospital of Harbin Medical University

Daqing Oil Field Hospital

Cangzhou Central Hospital

Yuncheng Central Hospital

Shenyang Sunshine Pharmaceutical Co., LTD.

Information provided by (Responsible Party):

Zhang Lei, MD, Institute of Hematology & Blood Diseases Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Previously Treated Primary Immune Thrombocytopenia	Drug: rhTPO Drug: Eltrombopag	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	175 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official 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
Actual Study Start Date :	November 22, 2022
Estimated Primary Completion Date :	June 2024
Estimated Study Completion Date :	December 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Immune thrombocytopenia Thrombotic thrombocytopenic purpura

Drug Information available for: Eltrombopag

Genetic and Rare Diseases Information Center resources: Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura

U.S. FDA Resources

Arms and Interventions

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 Name: Eltrombopag olamine

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.
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.
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.
3 months response [ Time Frame: after 3 months treatment ]
3 months response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 3 months.
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.
Time to treatment failure [ Time Frame: in 6 weeks treatment ]
Treatment failure is defined as:
- a platelet count ≤ 20 x 109/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).
Incidence of adverse events [ Time Frame: from study start date to the end of follow-up, up to 6 weeks ]
treatment-related adverse events.
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 weeks ]
Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0
Number of subjects who develop anti-rhTPO antibodies [ Time Frame: from study start date to the end of follow-up, up to 6 weeks ]
Number of subjects who develop anti-rhTPO antibodies
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05583838

Contacts

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Contact: Lei Zhang, MD	+86-22-23909240	zhanglei1@ihcams.ac.cn
Contact: Yunfei Chen, MD	+86-22-23909009	chenyunfei@ihcams.ac.cn

Locations

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China, Guangdong
Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Not yet recruiting
Guangzhou, Guangdong, China, 510030
Contact: Liping Ma
China, Guangxi
The Second Affiliated Hospital of Guangxi Medical University	Not yet recruiting
Nanning, Guangxi, China, 530007
Contact: Yinghui Lai
China, Hebei
Cangzhou Central Hospital	Not yet recruiting
Cangzhou, Hebei, China, 062650
Contact: Guohong Su
the Second Hospital of HeBei Medical University	Not yet recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Jianmin Luo
China, Heibei
North China University of Science and Technology Affiliated Hospital	Not yet recruiting
Tangshan, Heibei, China, 063000
Contact: Zhenyu Yan
China, Heilongjiang
The Daqing Oilfield General Hospital	Not yet recruiting
Daqing, Heilongjiang, China, 163000
Contact: Yun Li
The Second Affiliated Hospital of Harbin Medical University	Not yet recruiting
Harbin, Heilongjiang, China, 150000
Contact: Wei Wang
China, Henan
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital	Not yet recruiting
Zhengzhou, Henan, China, 450008
Contact: Hu Zhou
China, Inner Mongolia
The Affiliated Hospital of Inner Mongolia Medical University	Not yet recruiting
Hohhot, Inner Mongolia, China, 010107
Contact: Da Gao
China, Liaoning
The Second Hospital of Dalian Medical University	Not yet recruiting
Dalian, Liaoning, China, 116000
Contact: Jinsong Yan
China, Shaanxi
Xijing Hospital of the Fourth Military Medical University	Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: Guangxun Gao
Shaanxi Provincial People's Hospital	Not yet recruiting
Xi'an, Shaanxi, China, 710068
Contact: Yi Wang
China, Shanxi
Second Hospital of Shanxi Medical University	Not yet recruiting
Taiyuan, Shanxi, China, 030001
Contact: Yanping Ma
Yuncheng Central Hospital	Not yet recruiting
Yuncheng, Shanxi, China, 044099
Contact: Lixiang Duan
China, Tianjin
Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC	Recruiting
Tianjin, Tianjin, China, 300020
Contact: Lei Zhang, MD +86-22-23909240 zhanglei1@ihcams.ac.cn
Contact: Yunfei Yunfei, MD +86-22-23909009 chenyunfei@ihcams.ac.cn
Principal Investigator: Lei Zhang, MD
Sub-Investigator: Yunfei Chen, MD
China, Yunnan
The Second Affiliated Hospital of Kunming Medical University	Not yet recruiting
Kunming, Yunnan, China, 650101
Contact: Zeping Zhou

Sponsors and Collaborators

Institute of Hematology & Blood Diseases Hospital