Randomized, open-label, multicenter study to compare the efficacy and safety of combination of tacrolimus and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).
The investigators are undertaking a randomized controlled trial of 120 adults with steroid-resistant/relapse ITP in China. Patients were randomized to tacrolimus plus danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGSustained response
Sustained response was defines as the maintenance of platelet count ≥ 30 x 10\^9/L, and at least 2-fold increase of the baseline count, and the absence of bleeding, and no need for rescue medication at the 6-month follow-up.
Time frame: 6 months
Complete response
Complete response was defines as the maintenance of platelet count ≥ 100 x 10\^9/L, and at least 2-fold increase of the baseline count, and the absence of bleeding, and no need for rescue medication.
Time frame: 6 months
Response
Response was defines as the maintenance of platelet count ≥ 30 x 10\^9/L, and at least 2-fold increase of the baseline count, and the absence of bleeding, and no need for rescue medication.
Time frame: 6 months
Time to response
Time to response was defined as the time from starting treatment to the time to achieve the response.
Time frame: 6 months
Duration of response
Duration of response was measured from the achievement of response to the loss of response.
Time frame: 6 months
Adverse events
Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.