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Tests treatment safety and results for Herombopag
Official title A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP
ClinicalTrials.gov ID: NCT06838949
What this study is testing
What is herombopag olamine tablets?
herombopag olamine tablets is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for herombopag.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Patients voluntarily participated in the study and signed informed consent;
- Age ≥60 years old, gender unlimited;
- ECOG PS ≤2;
- Expected survival ≥6 months;
- A definitive diagnosis of ITP, including newly diagnosed, chronic, and persistent ITP;
You likely can't join if
- Patients who did not respond to previous treatment with herombopag;
- A history of allergy to thrombopoietin receptor agonist (TPO-RA) drugs;
- Combined with other important organ dysfunction, such as liver and kidney failure, cardiac insufficiency, etc.
- Secondary thrombocytopenia, such as rheumatic immune disease, chronic liver disease, hyperlienism, malignant hematologic disease, bone marrow...
- Receive TPO-RA medication within 2 weeks prior to treatment;
- Non-steroidal anti-inflammatory drugs (aspirin, salicylate, etc.) and anticoagulants (warfarin, clopidogrel, etc.) should be taken during treatment...
See the full eligibility criteria
- Patients voluntarily participated in the study and signed informed consent;
- Age ≥60 years old, gender unlimited;
- ECOG PS ≤2;
- Expected survival ≥6 months;
- A definitive diagnosis of ITP, including newly diagnosed, chronic, and persistent ITP;
- PLT \< 30×109/L for at least two consecutive times with an interval of at least 1 day before medication
- Patients with laboratory test results meet the following criteria: a. alanine aminotransferase (ALT) 3.0 x or less normal limit (ULN), aspartate aminotransferase (AST) 3.0 x ULN or less; b. Serum total bilirubin...
- The researchers determined that patients could be treated with hexapopal.
- Patients who did not respond to previous treatment with herombopag;
- A history of allergy to thrombopoietin receptor agonist (TPO-RA) drugs;
- Combined with other important organ dysfunction, such as liver and kidney failure, cardiac insufficiency, etc.
- Secondary thrombocytopenia, such as rheumatic immune disease, chronic liver disease, hyperlienism, malignant hematologic disease, bone marrow hematopoietic exhaustion disease (such as AA, MDS), hereditary...
- Receive TPO-RA medication within 2 weeks prior to treatment;
- Non-steroidal anti-inflammatory drugs (aspirin, salicylate, etc.) and anticoagulants (warfarin, clopidogrel, etc.) should be taken during treatment, which have an impact on platelet function.
- There are severe active bleeding symptoms, such as gastrointestinal bleeding, intracranial bleeding, etc.
- Severe thrombotic disease, such as transient ischemic attack, myocardial infarction, pulmonary embolism, deep vein thrombosis, and disseminated intravascular coagulation (DIC), occurred within 6 months prior to the...
- Have a New York Heart Society (NYHA) Class 3 or 4 congestive heart failure, or have a history of NYHA Class 3/4 congestive heart failure with a left ejection fraction (LVEF) of \< 45% within 4 weeks prior to treatment;
- Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody; Hepatitis virus positive, such as HBV, HCV, etc.
- A history of cirrhosis;
- Bone marrow reticulum fiber staining (MF) ≥2 grade;
- Have an active infection that is difficult to control;
- Have a history of or accompanied by malignant tumors;
- Pregnant or lactating women;
- Any other conditions that the investigator determines are not suitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.