Status:
COMPLETED
Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura
Lead Sponsor:
Humanity & Health Medical Group Limited
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Current first line treatments for immune thrombocytopenia (ITP) usually have transient effects and prolonged platelet response rate off therapy remains low. The aim is to evaluate whether a 12-week co...
Eligibility Criteria
Inclusion
- Subject has signed and dated a written informed consent.
- Adults (≥18 years) diagnosed with ITP according to the American Society for Hematology/British Committee for Standards in Haematology (ASH/BCSH) Guidelines. In addition, the peripheral blood smear should support the diagnosis of ITP with no evidence of other disease causative of thrombocytopenia (e.g., pseudo thrombocytopenia, myelofibrosis). The physical examination should be normal or at least not show signs suggestive of any disease likely to be associated with thrombocytopenia.
- No prior ITP treatment except platelet transfusions
- Subject has no intercurrent medical event, including evidence of any thrombosis.
- Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT), no history of hypercoagulable state.
- The following clinical chemistries must be within the normal reference range:
- creatinine, ALT, AST, total bilirubin, total albumin and alkaline phosphatase.
- Subject is practicing an acceptable method of contraception (documented in chart).
- Subject is able to understand and comply with protocol requirements and instructions.
Exclusion
- Any clinically relevant abnormality, other than ITP, identified on the screening examination, or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another diagnosis.
- History of active malignancy or on cancer therapy. Patients with a history of malignancy in complete remission for longer than 5 years are eligible
- History of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism).
- ≥ two of the following risk factors: Factor V Leiden, hormone replacement therapy, systemic contraception containing estrogen, smoking, diabetes, hypercholesterolemia, medications for hypertension or cancer.
- Pre-existing cardiac disease (including congestive heart failure, and arrhythmia requiring treatment), or clinically significant findings on resting 12-lead ECG at screening.
- Female subjects who are nursing or pregnant (positive serum or urine β-human chorionic gonadotrophin (β-hCG) pregnancy test) at screening or pre-dose on Day 1.
- History of alcohol/drug abuse.
- Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03830749
Start Date
July 1 2018
End Date
March 31 2023
Last Update
February 28 2024
Active Locations (1)
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1
Humanity & Health Research Centre
Hong Kong, Hong Kong SAR, Hong Kong