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
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|Condition or disease||Intervention/treatment||Phase|
|Previously Treated Primary Immune Thrombocytopenia||Drug: rhTPO Drug: Eltrombopag||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Optimized rhTPO treatment
The study in a 2:1 randomization ratio (117 subjects to rhTPO group).
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.
Active Comparator: Eltrombopag treatment
The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).
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
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Contact: Lei Zhang, MDemail@example.com|
|Contact: Yunfei Chen, MDfirstname.lastname@example.org|
|Sun Yat-sen Memorial Hospital of Sun Yat-sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510030|
|Contact: Liping Ma|
|The Second Affiliated Hospital of Guangxi Medical University||Not yet recruiting|
|Nanning, Guangxi, China, 530007|
|Contact: Yinghui Lai|
|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|
|North China University of Science and Technology Affiliated Hospital||Not yet recruiting|
|Tangshan, Heibei, China, 063000|
|Contact: Zhenyu Yan|
|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|
|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|
|The Second Hospital of Dalian Medical University||Not yet recruiting|
|Dalian, Liaoning, China, 116000|
|Contact: Jinsong Yan|
|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|
|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|
|Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC||Recruiting|
|Tianjin, Tianjin, China, 300020|
|Contact: Lei Zhang, MD +86-22-23909240 email@example.com|
|Contact: Yunfei Yunfei, MD +86-22-23909009 firstname.lastname@example.org|
|Principal Investigator: Lei Zhang, MD|
|Sub-Investigator: Yunfei Chen, MD|
|The Second Affiliated Hospital of Kunming Medical University||Not yet recruiting|
|Kunming, Yunnan, China, 650101|
|Contact: Zeping Zhou|
|Principal Investigator:||Lei Zhang, MD||Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC|
|Responsible Party:||Zhang Lei, MD, Professor/Vice director of Thrombosis &Hemostasis Center, Institute of Hematology & Blood Diseases Hospital|
|Other Study ID Numbers:||
|First Posted:||October 18, 2022 Key Record Dates|
|Last Update Posted:||January 26, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||From 12 months 36 months after study completion.|
|Access Criteria:||Upon request to PI.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Primary Immune Thrombocytopenia
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Blood Coagulation Disorders