Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Third People's Hospital of Chengdu

About this trial

This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old; diagnosis of immune thrombocytopenia.

Platelets ≤75×10^9/L before scheduled elective surgery.

Disqualifiers

History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;

Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;

Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);

Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;

Trial design

Design model

Single group

Treatments tested in this trial

  • Hetrombopag

    Drug

    Hetrombopag 7.5 mg, once a day, at bedtime for up to 14 days, drug administration was stopped when PLT≥100 ×10\^9/L, and take blood routine examination weekly, drug administration was resumed when PLT \< 100 ×10\^9/L. When PLT ≤30× 10\^9/L or ≥300 ×10\^9/L, take blood routine examination every 3 days.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Experimental: Hetrombopag armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Platelet elevation

Proportion of patients achieving perioperative platelet count goals (≥80×10\^9/ L for major surgery and ≥50×10\^9/ L for minor surgery) without emergency treatment

Time frame
up to 14 days

Secondary outcomes

1

Secondary Outcome

The median time to reach the platelet count target;

Time frame
up to 14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Third People's Hospital of Chengdu

Lead sponsor

Affiliated Hospital of North Sichuan Medical College

Collaborator