NCT06838949 A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP
| NCT ID | NCT06838949 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Herombopag |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-03-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.
Eligibility Criteria
Inclusion 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 ≤1.5×ULN; c. Serum creatinine ≤1.5×ULN; * The researchers determined that patients could be treated with hexapopal. Exclusion Criteria: * 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 thrombocytopenia, CVID, drug-induced thrombocytopenia, etc.; * 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 screening period; * 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.
Contact & Investigator
Yunfei Chen
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Science and Blood Disease Hospital
Frequently Asked Questions
Who can join the NCT06838949 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Herombopag. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06838949 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06838949 currently recruiting?
Yes, NCT06838949 is actively recruiting participants. Contact the research team at chenyunfei@ihcams.ac.cn for enrollment information.
Where is the NCT06838949 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06838949 clinical trial?
NCT06838949 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Yunfei Chen at Chinese Academy of Medical Science and Blood Disease Hospital. The trial plans to enroll 80 participants.