Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
Primary Purpose
ITP
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
TPO
Sponsored by
About this trial
This is an interventional treatment trial for ITP
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old, male or female
- For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
- Recurrence after previous treatment with glucocorticoids is ineffective or effective
- No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
- Platelet count before enrollment ≤ 30 × 109 / L, or > 30 × 109 / L but with active bleeding
- Volunteer to participate in the study and sign the informed consent form
Exclusion Criteria:
- pregnant or lactating
- Those with a history of thrombosis
- severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
- Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
- In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
- Severe or uncontrollable infections
- have a history of mental illness
- The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.
Sites / Locations
- The First Affiliated Hospital of Anhui Medical University
- Zhongshan Hospital Xiamen University
- The Second Affiliated Hospital of Guangzhou Medical University
- Guangdong Second People's Hospital
- Guangzhou Panyu Central Hospital
- Harbin Institute of Hematology and Oncology
- Henan University of Science and Technology First Affiliated Hospital
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
- Zhengzhou Central Hospital
- renmin Hospital of Wuhan University Hubei General Hospital
- Loudi Central Hospital
- The Second Affiliated Hospital of Soochow University
- The First Hospital of China Medical University
- First Affiliated Hospital Heilongjiang University of Chinese Medicine
- Xi An Central Hospital
- Chinese Academy of Medical Sciences Blood Disease Hospital
- Xinjiang Uygur Autonomous Region Chinese Medicine Hospital,
- Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine
- Lishui City Center Hospital
- The First Affiliated Hospital of Xinjiang Medical University
- Xinxiang Central Hospital,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
experimental group 1
experimental group 2
experimental group 3
experimental group 4
Arm Description
rhTPO injection7500 U ;one time a day; 14 times of administration
rhTPO injection15000 U;one time a day;14 times of administration
rhTPO injection15000 U;1 time every other day, 7 times;
rhTPO injection30000 U;1 time every other day, 7 times;
Outcomes
Primary Outcome Measures
The change in Platelet count from baseline on day 14 after the first dose
Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose.
Secondary Outcome Measures
The change in Platelet count from baseline on day 7 and day28 after the first dose
the total effective rate of treatment in ITP patients on day 7 and day 28
AE
Incidence of anti-rhTPO antibodies
Cav
average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state
AUCss
Full Information
NCT ID
NCT04089267
First Posted
September 10, 2019
Last Updated
September 12, 2019
Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04089267
Brief Title
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
Official Title
Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).
Detailed Description
Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, randomized, open, parallel controlled study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ITP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group 1
Arm Type
Experimental
Arm Description
rhTPO injection7500 U ;one time a day; 14 times of administration
Arm Title
experimental group 2
Arm Type
Experimental
Arm Description
rhTPO injection15000 U;one time a day;14 times of administration
Arm Title
experimental group 3
Arm Type
Experimental
Arm Description
rhTPO injection15000 U;1 time every other day, 7 times;
Arm Title
experimental group 4
Arm Type
Experimental
Arm Description
rhTPO injection30000 U;1 time every other day, 7 times;
Intervention Type
Drug
Intervention Name(s)
TPO
Primary Outcome Measure Information:
Title
The change in Platelet count from baseline on day 14 after the first dose
Time Frame
for day 14
Title
Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose.
Time Frame
for day 14
Secondary Outcome Measure Information:
Title
The change in Platelet count from baseline on day 7 and day28 after the first dose
Time Frame
for day7and day28
Title
the total effective rate of treatment in ITP patients on day 7 and day 28
Time Frame
for day7and day28
Title
AE
Time Frame
up to 28days
Title
Incidence of anti-rhTPO antibodies
Time Frame
up to 28days
Title
Cav
Description
average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state
Time Frame
up to 28days
Title
AUCss
Time Frame
up to 28days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old, male or female
For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
Recurrence after previous treatment with glucocorticoids is ineffective or effective
No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
Platelet count before enrollment ≤ 30 × 109 / L, or > 30 × 109 / L but with active bleeding
Volunteer to participate in the study and sign the informed consent form
Exclusion Criteria:
pregnant or lactating
Those with a history of thrombosis
severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
Severe or uncontrollable infections
have a history of mental illness
The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Facility Name
Guangdong Second People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510317
Country
China
Facility Name
Guangzhou Panyu Central Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511400
Country
China
Facility Name
Harbin Institute of Hematology and Oncology
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150010
Country
China
Facility Name
Henan University of Science and Technology First Affiliated Hospital
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Zhengzhou Central Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450007
Country
China
Facility Name
renmin Hospital of Wuhan University Hubei General Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Loudi Central Hospital
City
Loudi
State/Province
Hunan
ZIP/Postal Code
417118
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
First Affiliated Hospital Heilongjiang University of Chinese Medicine
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
150040
Country
China
Facility Name
Xi An Central Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710499
Country
China
Facility Name
Chinese Academy of Medical Sciences Blood Disease Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Xinjiang Uygur Autonomous Region Chinese Medicine Hospital,
City
Urumqi
State/Province
Xinjiang
Country
China
Facility Name
Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Lishui City Center Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Xinjiang
Country
China
Facility Name
Xinxiang Central Hospital,
City
Xinxiang
ZIP/Postal Code
453699
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
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