Efficacy and Safety of TPO Receptor Agonists in the Treatment of Elderly ITP Patients

Last updated: March 28, 2022
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Not Recruiting

Phase

4

Condition

Dysfunctional Uterine Bleeding

Platelet Disorders

Thrombosis

Treatment

N/A

Clinical Study ID

NCT05311930
TPO-RAs-old patients
  • Ages 60-100
  • All Genders

Study Summary

Elderly ITP patients have many underlying diseases, hormone contraindications and many adverse reactions during the use of hormones. TPO-RAs are oral small-molecule non-peptide drugs. Retrospective studies have shown that they have good efficacy and high safety in elderly patients. Therefore, this study is a prospective trial to evaluate TPO-RAs as the first-choice drug for the treatment of elderly ITP patients with contraindications to hormones, aiming to improve the efficacy-risk ratio of elderly patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. The patient voluntarily signed the informed consent; 2. The patient is a newlydiagnosed ITP patient, aged ≥60 years old; 3. Two consecutive PLTs < 30×109/L, or twoconsecutive PLTs < 30×109/L≤PLT<50×109/L but with risk factors such as bleeding (suchas previous bleeding history and/or anticoagulation/antiplatelet) Concomitantmedication) or age > 75 years; 4. Have not received first-line treatment such ashormones, IVIG, etc.; 5. There is any hormonal contraindication (with active pepticulcer, recent gastrointestinal anastomosis, corneal ulcer, severe hypertension (highblood pressure ≥ grade 2), diabetes with poor blood sugar control, infection thatcannot be controlled by antibiotics ( Bacterial and viral infections), heart failureand adrenal hyperfunction, severe mental illnesses such as epilepsy, severeosteoporosis, rheumatoid arthritis, tuberculosis, fractures, patients with combinedantithrombotic and antiplatelet drugs, etc.); 6. The following clinical biochemicalindicators must be within ±20% of the upper and lower limits of normal values:creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin andalkaline phosphatase.

Exclusion

Exclusion Criteria:

    1. Exclude immune diseases such as systemic lupus erythematosus, antiphospholipidsyndrome, etc.; 2. Exclude drug-related thrombocytopenia; 3. Bone marrow-relatedexaminations suggest the presence of other primary diseases of the blood system (suchas MDS, AA, thrombotic thrombocytopenic purpura, etc.) or the presence ofmyelofibrosis MF≥2; 4. Participated in other clinical trials affecting platelet countand function 3 months before the trial; 5. Previously received first-line therapy suchas hormones, IVIG; 6. Previous use of TPO-RAs or poor efficacy against known TPOdrugs; 7. The patient has experienced severe arterial or venous thrombosis (stroke,transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonaryembolism), or clinical symptoms suggest thrombophilia; 8. HIV, hepatitis B or Cseropositive or a history of liver cirrhosis or portal hypertension; 9.Life-threatening bleeding (WHO bleeding score 4) or the patient is expected to requiresalvage treatment before the first dose; 10. Has a history of malignant tumor or isaccompanied by malignant tumor; 11. The investigator believes that there are any othercircumstances that may cause the subjects to fail to complete the study or bringobvious risks to the subjects.

Study Design

Total Participants: 69
Study Start date:
May 01, 2022
Estimated Completion Date:
December 30, 2024

Study Description

Primary immune thrombocytopenia (ITP) is an immune disorder characterized by decreased production and increased destruction of platelets. In recent years, with the in-depth exploration of its pathogenesis and the continuous influx of new drugs, the status of second-line treatment drugs, mainly TPO receptor agonists (TPO-RAs), has been continuously improved, which has brought great importance to the treatment and management of ITP patients. However, for elderly ITP patients with severe underlying diseases, poor hormone tolerance, severe adverse reactions or hormone contraindications, whether TPO receptor agonists can be used as the first-choice drug and its efficacy and safety are still lacking relevant research, and for elderly ITP patients There is a lack of uniform guidelines for the treatment and management of patients. Limited retrospective studies have shown that TPO receptor agonists have good safety and efficacy, and are expected to become the recommended drugs for the treatment of elderly patients with ITP. However, whether TPO receptor agonists can be directly used as the first-choice drug for newly diagnosed elderly ITP patients who are not suitable for first-line treatment and its efficacy are uncertain.

This study will include newly diagnosed elderly ITP patients with hormonal contraindications or potential serious side effects of hormonal therapy, take the TPO-RA drug hetropoda as the first-choice treatment drug, and explore the effectiveness of hetrompopag in such patients and safety analysis. This study will provide new ideas and clinical basis for standardized and individualized treatment of elderly ITP patients, and provide practical experience for promoting the establishment of elderly ITP treatment guidelines.