rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP
rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP
The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known
 hospitals in China. In order to report the efficacy and safety of Recombinant Human
 thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune
 thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.
The investigators are undertaking a parallel group, multicentre, randomised controlled trial
 of 200 primary ITP adult patients from 14 medical centers in China. One part of the
 participants are randomly selected to receive recombinant human thrombopoietin (given
 subcutaneously at a dose of 300Units/kg for7-14 consecutive days, following with a flexible
 dosage depending on platelet count until the 28th day), combining with dexamethasone (given
 intravenously at a dose of 40 mg per day for 4days, the others are selected to receive
 high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4
 days). Platelet count was evaluated before and after treatment, in order to report the
 conversion ratio of primary ITP to chronic ITP.
Inclusion Criteria:

 1. Meet the diagnostic criteria for immune thrombocytopenia.

 2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80
 years.

 3. To show a platelet count < 30×10^9/L, and with bleeding manifestations.

 4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.

 5. Willing and able to sign written informed consent.

 Exclusion Criteria:

 1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts
 within 3 months before the screening visit.

 2. Received high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the
 3 weeks prior to the start of the study.

 3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.

 4. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or
 uncontrolled disease or condition related to or impacting cardiac function (e.g.,
 unstable angina, congestive heart failure, uncontrolled hypertension or cardiac
 arrhythmia)

 5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate
 pregnancy during the study period.

 6. Have a known diagnosis of other autoimmune diseases, established in the medical
 history and laboratory findings with positive results for the determination of
 antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct
 Coombs test.

 7. Patients who are deemed unsuitable for the study by the investigator.