Actively Recruiting
A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary Immune Thrombocytopenia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-03-13
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of herombopag to help elderly patients with immune thrombocytopenia (ITP), a condition that affects platelet levels in the blood. This phase 2 clinical trial focuses on patients aged 60 years and older to evaluate how well herombopag works and how safe it is for treating this condition in older adults. The study is designed as a single-arm, prospective trial involving 80 participants. Participants will take herombopag tablets starting at 5 mg once daily on an empty stomach, with the possibility to eat two hours afterward. The treatment lasts for 24 weeks, and the dosage may be adjusted weekly based on platelet counts, with a maximum of 7.5 mg per day. If there is no response after 8 weeks, patients may be advised to stop treatment but will continue safety monitoring for an additional 4 weeks. Treatment continues unless toxicity, disease progression, withdrawal of consent, or other criteria require stopping. Throughout the study, participants will have weekly blood tests to monitor platelet levels and overall safety, including vital signs and lab tests. Researchers will assess treatment effects at 8 weeks and 24 weeks, including platelet count improvements and bleeding symptoms. After treatment ends, a 4-week safety follow-up visit is conducted. The study aims to measure how many patients reach target platelet levels and track any adverse effects experienced during the study period.
CONDITIONS
Brief 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 participate and sign informed consent
- Age 60 years or older, any gender
- ECOG Performance Status of 2 or less
- Expected survival of 6 months or more
- Confirmed diagnosis of ITP (newly diagnosed, chronic, or persistent)
- Platelet count below 30 x 10^9/L on at least two occasions at least one day apart before medication
- Liver enzymes ALT and AST up to 3 times the normal limit
- Total bilirubin up to 1.5 times the normal limit
- Serum creatinine up to 1.5 times the normal limit
- Investigator determines patient can be treated with herombopag
You will not qualify if you...
- Lack of response to previous herombopag treatment
- Allergy to thrombopoietin receptor agonist drugs
- Significant organ dysfunction like liver failure, kidney failure, or heart failure
- Secondary thrombocytopenia caused by other diseases such as rheumatic immune disease or malignant blood disorders
- Use of TPO-RA medication within 2 weeks before treatment
- Use of NSAIDs or anticoagulants affecting platelet function during treatment
- Severe active bleeding like gastrointestinal or intracranial bleeding
- Severe thrombotic diseases within 6 months before screening
- NYHA Class 3 or 4 congestive heart failure or recent history with low ejection fraction
- Positive for HIV or hepatitis viruses
- History of cirrhosis
- Bone marrow fibrosis grade 2 or higher
- Active infections that are difficult to control
- History or presence of malignant tumors
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 24 weeks
Participants receive herombopag 5 mg once daily on an empty stomach for up to 24 weeks. Dosage may be adjusted weekly based on platelet counts. Participants continue treatment until intolerable toxicity, disease progression, withdrawal, or other criteria occur. Blood tests and safety assessments occur weekly.
Weekly visits for treatment and safety assessments
Duration - 4 weeks
Participants who discontinue treatment due to lack of response or safety concerns continue safety monitoring for 4 weeks after treatment ends.
1 safety follow-up visit
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
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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