Idiopathic Thrombocytopenic Purpura
Conditions
Interventions
Sponsors
NATIONAL KYUSHU MEDICAL CENTER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)age >18, <80 2)newly diagnosed untreated ITP adult patients 3)Platelet count<20*10^9/L 4)Platelet count>20*10^9/L and <50*10^9/L plus bleeding symptom. 5)PS 0 to 2 6)Patients received a fully described on the basis of informed consent document, by the free will of the person that consent is obtained in writing with respect to participation in the study. In the case of minors, it is acceptable in the approval of the guardian
Exclusion criteria
Exclusion criteria: 1)Active malignancy at time of study entry 2)Concomitant treatment with anti-platelet and or anti-coagulant drugs 3)Concomitant severe psychiatric disorders 4)Women who are pregnant or breastfeeding 5)Cardiovascular diseases requiring treatment 6)Severe non-controlled, despite therapy, hypertension and diabetes 7)Liver and kidney function impairment (creatinine, ALT, AST >2 times upper normal limit) 8)HCVAb, HIVAb, HBsAg seropositive status 9)Chronic liver disease 10)Documented viral illness by the positivity of IgM, or vaccination both occurred one month before diagnosis 11)Intake of drugs not previously taken within one week before diagnosis 12) Active gastric ulcer. 13)Severe intracranial bleeding or GI bleeding 14)Presence of autoimmune hemolytic anemia 15) Continuous administration of steroid hormone or immunosuppressive agents for other disease. 16)Not appropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete and partial response rate at 180 days from finish up dexamethasone pulse therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet count at 46+180 days. Relapse free survival Adverse event occurrence rate. H,pyroli infection rate. Therapeutic effect by eradication of H.pyroli. Relapse free survival rate at 46+180days with or without H.pyroli infection. Adverse event occurrence rate with or without eradication of H.pyroli. | — |
Countries
Japan
Contacts
Public ContactMari Egawa
NATIONAL KYUSHU MEDICAL CENTER Hematology
Outcome results
None listed