This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .
The primary objective of this study was to evaluate the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years who had not responded to first-line in the previous treatment. 100 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10\^9/L and 150×10\^9/L according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10\^9/L, the treatment was stopped. If the platelet count is more than 400×10\^9/L after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGTreatment response
Percentage of participants whose platelet count achieving response (R) within 6weeks.
Time frame: From the start of study treatment (Day 1) up to the end of week 6
Treatment response
Percentage of participants achieving a platelet count \>=50×10\^9/L at week 1,2,3,4,5and 6 of treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Treatment response
Percentage of participants achieving a platelet count \>=100×10\^9/L at week 1,2,3,4,5and 6 of treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Duration of response
Percentage of participants whose platelet count achieving persistence response (R) within 6weeks(defined as the proportion of subjects with a platelet count of ≥30×109/L for at least 4 weeks of the 6-week treatment period without remedial therapy).
Time frame: From the start of study treatment (Day 1) up to the end of week 6
Concomitant medication
The percentage of patients with reduced concomitant medication, reduced bleeding and remedial treatment.
Time frame: From the start of study treatment (Day 1) up to the end of week 6
Adverse events
Incidence of adverse events.
Time frame: From the start of study treatment (Day 1) up to the end of week 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.