A randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (ITP).
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 228 adults with ITP in China. Patients were randomized to terbutaline plus danazol compared to 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
SINGLE
Enrollment
228
Orally terbutaline at a dose of 2.5 mg three times daily for 16 weeks
Orally danazol at a dose of 200 mg twice daily for 16 weeks
Overall response
Achieving a platelet count ≥ 30 × 10\^9/L confirmed on at least two separate occasions (at least 7 days apart), at least a doubling of the baseline platelet count without any other ITP-specific treatment and the absence of bleeding.
Time frame: From date of randomization until 1 years or the end of follow-up
Sustained response
maintenance of a platelet count \> 30 × 10\^9/L, an absence of bleeding, and no requirement for any other ITP-specific treatment for 6 consecutive months after achievement of OR
Time frame: From date of randomization until 1 years or the end of follow-up
Complete response
a platelet count ≥ 100 × 10\^9/L measured on two occasions at least 7 days apart and the absence of bleeding
Time frame: From date of randomization until 1 years or the end of follow-up
Remission
a durable platelet count \> 30 × 109/L without bleeding up to 12 months after randomization
Time frame: at 12-month follow-up
Time to response
the time from starting treatment to the time a response was achieved.
Time frame: From date of randomization until 1 years or the end of follow-up
Duration of response
time from OR until loss of response or until the last follow-up visit
Time frame: From date of randomization until 1 years or the end of follow-up
Rescue therapy
any new medical intervention taken to increase the platelet count or prevent bleeding events or an increase in the dose of concomitant treatments
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From date of randomization until 1 years or the end of follow-up
Associated factors of treatment failure, OR, SR and remission
Factors that are associated with treatment failure, OR, SR and remission
Time frame: From date of randomization until 1 years or the end of follow-up
Number of patients with bleeding
Number of patients with bleeding complication (WHO bleeding score)
Time frame: From date of randomization until 1 years or the end of follow-up
Number of patients with side effects
Number of patients with Medication adverse events.
Time frame: From date of randomization until 1 years or the end of follow-up
Relapse
Loss of OR
Time frame: From date of randomization until 1 years or the end of follow-up
Relapse-free survival
the time interval between achievement of OR and relapse or the end of the follow-up
Time frame: From date of randomization until 1 years or the end of follow-up