About this trial
The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients voluntarily participated in the study and signed informed consent;
Age ≥60 years old, gender unlimited;
ECOG PS ≤2;
Expected survival ≥6 months;
Disqualifiers
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.;
Trial design
Single group
Treatments tested in this trial
herombopag olamine tablets
DrugThe patient received herombopag 5mg/d at the beginning of the day, was orally taken on an empty stomach in the morning, and could eat 2 hours after taking the drug, once a day for 24 weeks. Investigators will adjust the dosage of herombopag once a week according to the platelet count, with a maximum dosage of 7.5 mg per day. Efficacy and safety were evaluated once a week.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with platelet count ≥30×109/L
Proportion of subjects with a platelet count ≥ 30 × 10\^9/L and at least twice the baseline platelet count without bleeding at week 8
Secondary outcomes
Proportion of patients with platelet count ≥50×109/L
Proportion of patients with platelet count ≥50×109/L within 8 weeks of treatment
Proportion of patients with platelet count ≥100×109/L
Proportion of patients who achieved CR within 8 weeks of treatment
Duration from treatment initiation to platelet count ≥30×10^9/L and ≥50×10^9/L
The time of first Platelet≥30×109/L and ≥50×109/L
Sustained response at 24 weeks of treatment
Sustained response at 24 weeks of treatment defined as 8 weeks after the last visit, at least 6 visits with platelets ≥30×109/L, greater than 2 times of baseline, and no bleeding
Sponsors and contacts
Click on the lead sponsor to view all of their trials.