immune thrombocytopenia (ITP)
Conditions
Interventions
1:eltrombopag 25-75mg daily for 3 months plus pulsed dexamethasone, 40mg daily for 4 days repeated every 4 weeks for 1-3 courses
Sponsors
University Hospital, Macau
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Subject has signed and dated a written informed consent. 2. 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. 3. No prior ITP treatment except platelet transfusions 4. Subject has no intercurrent medical event, including evidence of any thrombosis. 5. Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT), no history of hypercoagulable state. 6. The following clinical chemistries must be within the normal reference range: creatinine, ALT, AST, total bilirubin, total albumin and alkaline phosphatase. 7. Subject is practicing an acceptable method of contraception (documented in chart). 8. Subject is able to understand and comply with protocol requirements and instructions.
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply 1. 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. 2. History of active malignancy or on cancer therapy. Patients with a history of malignancy in complete remission for longer than 5 years are eligible 3. History of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism). 4. = two of the following risk factors: Factor V Leiden, hormone replacement therapy, systemic contraception containing estrogen, smoking, diabetes, hypercholesterolemia, medications for hypertension or cancer. 5. Pre-existing cardiac disease (including congestive heart failure, and arrhythmia requiring treatment), or clinically significant findings on resting 12-lead ECG at screening. 6. Female subjects who are nursing or pregnant (positive serum or urine ß-human chorionic gonadotrophin (ß-hCG) pregnancy test) at screening or pre-dose on Day 1. 7. History of alcohol/drug abuse. 8. Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prolonged response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Early response rate; | — |
Countries
China
Contacts
Public ContactGregory Cheng
University Hospital, Macau
Outcome results
None listed