Status:
UNKNOWN
A Study of Switching Avatrombopag and Rh-TPO in ITP
Lead Sponsor:
Peking University People's Hospital
Conditions:
Corticosteroid-resistant or Relapsed ITP
Eligibility:
All Genders
18-75 years
Brief Summary
Thrombopoietin receptor agonists (TPO-RAs) represent a highly effective and well-tolerated second-line ITP treatment that provides excellent responses.If there is cross-resistance between 2 drugs for ...
Detailed Description
Thrombopoietin Receptor Agonists (TPO-RAs) are novel treatments for patients with chronic Primary Immune Thrombocytopenia (ITP). According to the findings of mechanism-based studies, rhTPO competes wi...
Eligibility Criteria
Inclusion
- 18 years or older 2.Primary ITP 3.Failed initial glucocorticosteroid treatment, 4.Applying rhTPO or Eltrombopag as subsequent treatment 5.Switch from rh-TPO to eltrombopag or vice versa 6.Normal neutrophils 7.Available follow-up at least 6 weeks after switching
Exclusion
- HIV positive status, or active infection of HBV or HCV
- Suffering from a serious or progressive disease, which, in the investigator's judgment, put the subject at undue risk for participation in this study (i.e. cancer or pre-cancer, immunocompromised, uncontrolled diabetes, epilepsy, severe cardio-cerebrovascular disease(s) (i.e. stroke, idiopathic aortic stenosis, aneurysm, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, tachyarrhythmias, severe heart failure \[classified as NYHA III-IV\], severe lung dysfunctions, etc))
- History of thrombosis plus two or more risk factors as defined in Caprini thrombosis risk assessment model
- Lactating or pregnant women, or WOCBP who are unwilling to use highly effective contraceptive measures during the study period
- Abnormal liver and renal functions: AST or ALT or total bilirubin ≥1.5 × ULN, and/or creatinine ≥176.8 μmol/L
- Women of childbearing potential (WOCBP) that are pregnant or wish to become pregnant during the prospective phase of the study.
- Other conditions which the investigator considers inappropriate for enrollment
Key Trial Info
Start Date :
June 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04913597
Start Date
June 20 2021
End Date
December 31 2023
Last Update
June 4 2021
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