Back to resultsHerombopag + rhTPO in Severe Immune Thrombocytopenia
Primary Purpose
Immune Thrombocytopenia
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rhTPO
Herombopag
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring immune thrombocytopenia, severe, Herombopag, recombinant human thrombopoietin
Eligibility Criteria
Inclusion Criteria:
- Male or female,70 ≥age≥18；
- Diagnosed as primary immune thrombocytopenia；
- Platelet count was less than 10 × 10E9 / L with active bleeding, or bleeding score ≥ 5 points；
- No use of IVIG, Avatrombopag, Eltrombopag or Romiplostim 2 weeks before treatment；
- Rituximab was used for at least 2 months, and other immunosuppressants were stable for at least 4 weeks.
- There was no history of platelet transfusion one week before treatment.
Exclusion Criteria:
- Secondary thrombocytopenia caused by other autoimmune diseases and virus infection was excluded；
- Patients with active malignant tumors, pregnancy, severe cardiovascular， cerebrovascular diseases and a history of arteriovenous thrombotic diseases were excluded；
- Patients deemed unsuitable for enrollment by the investigator；
- Patients with thrombotic disease or serious uncontrolled cardiovascular and cerebrovascular disease;
- Patients reject to participate in the study.
Sites / Locations
- Jie YinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
rhTPO
Herombopag
Herombopag in combination of rhTPO
Arm Description
rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days.
Herombopag will be taken orally at 5 mg daily for 28 days.
Herombopag will be taken orally at 5 mg daily for 28 days，while rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days
Outcomes
Primary Outcome Measures
Response Rate
platelets ≥30*10E9/L, and at least 2 times higher than the baseline platelet count, and there is no hemorrhagic manifestations
The rate and magnitude of the increase in platelet count
The rate and magnitude of the increase in platelet count after treatment
Platelet maintenance response time
Platelets stay above 30*10E9/L
Secondary Outcome Measures
Platelet fuction
Platelet aggregation function assay and the expression of P selectin on platelet surface
the markers of thrombosis and fibrinolysis
platelet-derived microparticals in plasma, concentration of Plasminogen Activator Inhibitor-1 （PAI-1）, D-D dimer, tissue plasminogen activator （tPA），urokinase-type plasminogen activator （uPA） and Thrombin activatable fibrinolysis inhibitor （TAFI）
Thrombotic events
the number/time/site of thrombotic events （lower extremity deep vein thrombosis, pulmonary embolism, intracranial thrombosis, .etc）in participants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05328804
Brief Title
Herombopag + rhTPO in Severe Immune Thrombocytopenia
Official Title
Evaluating the Efficacy and Safety of the Combination of Herombopag and Human Thrombopoietin (rhTPO) in the Treatment of Patients With Severe Immune Thrombocytopenia (ITP)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yin Jie
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
Severe immune thrombocytopenia (ITP) is a life-threatening acquired hemorrhagic disease with dramatically decreased platelet number and clinical bleeding symptoms. Some patients with severe ITP did not respond to first-line treatment including steroids and IVIG. It was critical for them to use effective treatments to promote platelet and reduce the risk of fatal bleeding. In this study, the patients with severe ITP will be treated with hetrombopag, rhTPO, and the combination of hetrombopag and rhTPO, respectively. The effect evaluation includes the increase of platelet number and decrease of bleeding scores. Changes of coagulation, platelet activation, fribrinolysis influence, and thrombotic events will also be accessed for the safety of treatments. The aim of this study is to demonstrate that the combination of hetrombopag and rhTPO for severe ITP is more effective than the other two monotherapy and does not increase thrombotic events or thrombosis risk.
Detailed Description
Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group. The effective rate of treatment, the rate and amplitude of platelet increase, the response time of platelet maintenance, and the effect of combination therapy on hemostasis will be compared. At the same time, the investigators will analyze the markers of thrombosis and thrombotic events to assess the safety of combination therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
immune thrombocytopenia, severe, Herombopag, recombinant human thrombopoietin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rhTPO
Arm Type
Experimental
Arm Description
rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days.
Arm Title
Herombopag
Arm Type
Experimental
Arm Description
Herombopag will be taken orally at 5 mg daily for 28 days.
Arm Title
Herombopag in combination of rhTPO
Arm Type
Experimental
Arm Description
Herombopag will be taken orally at 5 mg daily for 28 days，while rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days
Intervention Type
Drug
Intervention Name(s)
rhTPO
Intervention Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Herombopag
Intervention Description
Orally by mouth
Primary Outcome Measure Information:
Title
Response Rate
Description
platelets ≥30*10E9/L, and at least 2 times higher than the baseline platelet count, and there is no hemorrhagic manifestations
Time Frame
From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Title
The rate and magnitude of the increase in platelet count
Description
The rate and magnitude of the increase in platelet count after treatment
Time Frame
From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Title
Platelet maintenance response time
Description
Platelets stay above 30*10E9/L
Time Frame
From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Secondary Outcome Measure Information:
Title
Platelet fuction
Description
Platelet aggregation function assay and the expression of P selectin on platelet surface
Time Frame
From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Title
the markers of thrombosis and fibrinolysis
Description
platelet-derived microparticals in plasma, concentration of Plasminogen Activator Inhibitor-1 （PAI-1）, D-D dimer, tissue plasminogen activator （tPA），urokinase-type plasminogen activator （uPA） and Thrombin activatable fibrinolysis inhibitor （TAFI）
Time Frame
From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Title
Thrombotic events
Description
the number/time/site of thrombotic events （lower extremity deep vein thrombosis, pulmonary embolism, intracranial thrombosis, .etc）in participants
Time Frame
From randomization to 3 months after rhTPO/Herombopag/Herombopag+rhTPO treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female,70 ≥age≥18；
Diagnosed as primary immune thrombocytopenia；
Platelet count was less than 10 × 10E9 / L with active bleeding, or bleeding score ≥ 5 points；
No use of IVIG, Avatrombopag, Eltrombopag or Romiplostim 2 weeks before treatment；
Rituximab was used for at least 2 months, and other immunosuppressants were stable for at least 4 weeks.
There was no history of platelet transfusion one week before treatment.
Exclusion Criteria:
Secondary thrombocytopenia caused by other autoimmune diseases and virus infection was excluded；
Patients with active malignant tumors, pregnancy, severe cardiovascular， cerebrovascular diseases and a history of arteriovenous thrombotic diseases were excluded；
Patients deemed unsuitable for enrollment by the investigator；
Patients with thrombotic disease or serious uncontrolled cardiovascular and cerebrovascular disease;
Patients reject to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Tian
Phone
15850150032
Email
tianhong0718@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Yin
Organizational Affiliation
First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jie Yin
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Yin, MD.，PhD
Phone
+86-512-67781521
Email
yinjie@suda.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Herombopag + rhTPO in Severe Immune Thrombocytopenia
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