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/AClinical Study ID
NCT05311930
TPO-RAs-old patients
Ages 60-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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:
- 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