Status:
UNKNOWN
Herombopag + rhTPO in Severe Immune Thrombocytopenia
Lead Sponsor:
Yin Jie
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 no...
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 plat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05328804
Start Date
January 1 2022
End Date
December 31 2023
Last Update
April 26 2022
Active Locations (1)
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1
Jie Yin
Suzhou, Jiangsu, China