A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP

ConditionHerombopag
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • herombopag olamine tablets

    Drug

    The 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

80 Participants
are divided into 1 treatment group
Group A: HerombopagExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
8 weeks

Secondary outcomes

1

Proportion of patients with platelet count ≥50×109/L

Proportion of patients with platelet count ≥50×109/L within 8 weeks of treatment

Time frame
8 weeks
2

Proportion of patients with platelet count ≥100×109/L

Proportion of patients who achieved CR within 8 weeks of treatment

Time frame
8 weeks
3

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

Time frame
24 weeks
4

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

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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