Back to resultsA Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts (TE-ITP)
Primary Purpose
Previously Treated Primary Immune Thrombocytopenia
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rhTPO
Eltrombopag
Sponsored by
About this trial
This is an interventional treatment trial for Previously Treated Primary Immune Thrombocytopenia focused on measuring rhTPO, Eltrombopag, Pre-treated, Primary Immune Thrombocytopenia
Eligibility 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.
Sites / Locations
- The Second Affiliated Hospital of Guangxi Medical UniversityRecruiting
- the Second Hospital of HeBei Medical University
- North China University of Science and Technology Affiliated Hospital
- The Second Affiliated Hospital of Harbin Medical University
- Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalRecruiting
- The Affiliated Hospital of Inner Mongolia Medical UniversityRecruiting
- The Second Hospital of Dalian Medical UniversityRecruiting
- xi'an Central Hospital
- Xijing Hospital of the Fourth Military Medical UniversityRecruiting
- Shaanxi Provincial People's HospitalRecruiting
- Second Hospital of Shanxi Medical University
- Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMCRecruiting
- Kashgar District 1st People's Hospital
- People's Hospital of Xinjiang Uygur Autonomous Region
- The first affiliated Hospital of Xinjiang Medical University
- The Second Affiliated Hospital of Kunming Medical UniversityRecruiting
- The second Medical Center of PLA general hospital
- The second hospital of tianjin medical university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Optimized rhTPO treatment
Eltrombopag treatment
Arm Description
The study in a 2:1 randomization ratio (117 subjects to rhTPO group).
The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Early response
Early response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 week.
Initial response
Initial response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 month.
6 weeks response
6 weeks response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 weeks.
3 months response
3 months response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 3 months.
Durable response
Durable response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 months.
Time to treatment failure
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
treatment-related adverse events.
Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0
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
Number of subjects who develop anti-rhTPO antibodies
The duration time with platelet count ≥50x10^9/L
Total duration of time a subject had platelet count ≥50x10^9/L during treatment
Full Information
NCT ID
NCT05583838
First Posted
October 12, 2022
Last Updated
September 22, 2023
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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, The Second Affiliated Hospital of Dalian Medical University, Second Hospital of Shanxi Medical University, The Second Affiliated Hospital of Harbin Medical University, Shenyang Sunshine Pharmaceutical Co., LTD., First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, Kashgar 1st People's Hospital, Xi'an Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05583838
Brief Title
A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts
Acronym
TE-ITP
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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, The Second Affiliated Hospital of Dalian Medical University, Second Hospital of Shanxi Medical University, The Second Affiliated Hospital of Harbin Medical University, Shenyang Sunshine Pharmaceutical Co., LTD., First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, Kashgar 1st People's Hospital, Xi'an Central Hospital
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Previously Treated Primary Immune Thrombocytopenia
Keywords
rhTPO, Eltrombopag, Pre-treated, Primary Immune Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Optimized rhTPO treatment
Arm Type
Experimental
Arm Description
The study in a 2:1 randomization ratio (117 subjects to rhTPO group).
Arm Title
Eltrombopag treatment
Arm Type
Active Comparator
Arm Description
The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).
Intervention Type
Drug
Intervention Name(s)
rhTPO
Other Intervention Name(s)
Recombinant human thrombopoietin, TPIAO
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Eltrombopag
Other Intervention Name(s)
Eltrombopag olamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation
Description
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.
Time Frame
in 6 weeks treatment
Secondary Outcome Measure Information:
Title
Early response
Description
Early response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 week.
Time Frame
after 1 week treatment
Title
Initial response
Description
Initial response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 month.
Time Frame
after 1 month treatment
Title
6 weeks response
Description
6 weeks response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 weeks.
Time Frame
after 6 weeks treatment
Title
3 months response
Description
3 months response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 3 months.
Time Frame
after 3 months treatment
Title
Durable response
Description
Durable response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 months.
Time Frame
after 6 months treatment
Title
Time to treatment failure
Description
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).
Time Frame
in 6 weeks treatment
Title
Incidence of adverse events
Description
treatment-related adverse events.
Time Frame
from study start date to the end of follow-up, up to 6 weeks
Title
Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0
Description
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
Title
Number of subjects who develop anti-rhTPO antibodies
Description
Number of subjects who develop anti-rhTPO antibodies
Time Frame
from study start date to the end of follow-up, up to 6 weeks
Title
The duration time with platelet count ≥50x10^9/L
Description
Total duration of time a subject had platelet count ≥50x10^9/L during treatment
Time Frame
in 6 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Zhang, MD
Phone
+86-22-23909240
Email
zhanglei1@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yunfei Chen, MD
Phone
+86-22-23909009
Email
chenyunfei@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, MD
Organizational Affiliation
Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinghui Lai
Facility Name
the Second Hospital of HeBei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Luo
Facility Name
North China University of Science and Technology Affiliated Hospital
City
Tangshan
State/Province
Heibei
ZIP/Postal Code
063000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Yan
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang
Facility Name
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Zhou
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010107
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Da Gao
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsong Yan
Facility Name
xi'an Central Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangping Song, MD
Facility Name
Xijing Hospital of the Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangxun Gao
Facility Name
Shaanxi Provincial People's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Wang
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanping Ma
Facility Name
Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, MD
Phone
+86-22-23909240
Email
zhanglei1@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Yunfei Yunfei, MD
Phone
+86-22-23909009
Email
chenyunfei@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Lei Zhang, MD
First Name & Middle Initial & Last Name & Degree
Yunfei Chen, MD
Facility Name
Kashgar District 1st People's Hospital
City
Kashgar
State/Province
Xinjiang
ZIP/Postal Code
844000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abudureyimu Aikebaier, MD
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Mao, MD
Facility Name
The first affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinhong Guo, MD
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650101
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeping Zhou
Facility Name
The second Medical Center of PLA general hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuechun Lu, MD
Facility Name
The second hospital of tianjin medical university
City
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Bai, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
From 12 months 36 months after study completion.
IPD Sharing Access Criteria
Upon request to PI.
Learn more about this trial
A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts
We'll reach out to this number within 24 hrs