Immune Thrombocytopenia, Purpura, Thrombocytopenic
Conditions
Keywords
Immune Thrombocytopenia
Brief summary
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of atorvastatin for the treatment of adults with immune thrombocytopenia (ITP).
Detailed description
The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients, which have no indications of glucocorticoid therapy (platelets count \> 30\*10\^9/L )from Qilu Hospital of Shandong University in China.15 of the participants are randomly selected to receive atorvastatin in 20 mg/d combining with 10 mg/d for 6 months. Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of atorvastatin for the treatment of adults with ITP.
Interventions
DRUGAtorvastatin 20mg
Atorvastatin will be given in 20 mg po qn for 1 month
Atorvastatin will be given in 10 mg po qn for 1 month
DRUGDexamethasone
Dexamethasone will be given in 40mg po qd for 4 days
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Meet the diagnostic criteria for immune thrombocytopenia. 2. within 3 months from diagnosis,untreated patients, may be male orfemale, between the ages of 18 \ 80 years. 3. To show a platelet count \> 30×10\^9/L and without bleeding manifestations.
Exclusion criteria
1. Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts within 3 months before the screening visit. 2. Received steroids or other effective therapy for immune thrombocytopenia. 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. 5. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 7. 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. 8. Patients who are deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of platelet response | up to 1 year per subject | Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapy associated adverse events | up to 1 year per subject | The number and frequency of therapy associated adverse events |
Countries
China
Contacts
Primary ContactMing Hou, Dr
Outcome results
None listed