Actively Recruiting
A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-03-13
80
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.
CONDITIONS
Official Title
A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participated in the study and signed informed consent
- Age 60 years or older, any gender
- ECOG performance status 2 or less
- Expected survival of 6 months or more
- Confirmed diagnosis of primary immune thrombocytopenia (ITP), including newly diagnosed, chronic, or persistent
- Platelet count less than 30 x 10^9/L on at least two occasions at least 1 day apart before medication
- Laboratory tests with ALT and AST less than or equal to 3 times the upper limit of normal, total bilirubin less than or equal to 1.5 times upper limit, and serum creatinine less than or equal to 1.5 times upper limit
- Investigator determines patient can be treated with herombopag
You will not qualify if you...
- Patients who did not respond to previous treatment with herombopag
- History of allergy to thrombopoietin receptor agonists (TPO-RA)
- Severe organ dysfunction such as liver failure, kidney failure, or heart failure
- Secondary thrombocytopenia caused by other diseases such as rheumatic immune disease, chronic liver disease, malignant hematologic disease, bone marrow failure, hereditary thrombocytopenia, CVID, or drug-induced thrombocytopenia
- Use of TPO-RA medications within 2 weeks prior to treatment
- Use of non-steroidal anti-inflammatory drugs or anticoagulants that affect platelet function during treatment
- Severe active bleeding symptoms like gastrointestinal or intracranial bleeding
- Severe thrombotic diseases within 6 months before screening
- New York Heart Association Class 3 or 4 heart failure or history of it with low ejection fraction within 4 weeks prior to treatment
- Positive tests for HIV, syphilis, or hepatitis viruses
- History of cirrhosis
- Bone marrow fibrosis grade 2 or higher
- Active uncontrolled infection
- History or presence of malignant tumors
- Pregnant or lactating women
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese academy of medical science and blood disease hospital
Tianjin, China
Actively Recruiting
Research Team
Y
Yunfei Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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