Status:
UNKNOWN
The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
Lead Sponsor:
Peking University People's Hospital
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Single-arm, open-lable, multicentre study to compare the efficacy and safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with corticosteroidresistant/relapsed ITP...
Detailed Description
Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of corticosteroid-resistant or...
Eligibility Criteria
Inclusion
- ITP confirmed by excluding other supervened causes of thrombocytopenia;
- Platelet count of less than 30×10\^9/L at enrollment;
- Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
- ECOG\<2.
- EPCs in bone marrow less than 0.02%
Exclusion
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
- congestive heart failure
- severe arrhythmia
- nursing or pregnant women
- aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
- creatinine or serum bilirubin levels each 1.5 times or more than the normal range
- active or previous malignancy
- Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
Key Trial Info
Start Date :
March 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03460808
Start Date
March 10 2018
End Date
January 1 2023
Last Update
March 9 2018
Active Locations (1)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044