A single-arm, open-label study to evaluate the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia (ITP).
This is a prospective, open-label, Phase II, single-arm interventional trial performed in a single center in China. The investigators explore the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated on days 11 to 14 in the case of lack of response by day 10)
Acetylcysteine, po, 400mg tid, for 4 weeks
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGNumber of patients with durable response after 6 months
Number of patients with durable response after 6 months
Time frame: 6 months
Early response
Number of patients with early response on day 7
Time frame: 7 days
Initial response
Number of patients with initial response at 1 month
Time frame: 1 month
Bleeding
Number of patients with bleeding complication therapy; bleeding score
Time frame: 1 year
DOR
duration of response
Time frame: 1 year
Relapse
Number of patients relapse during the observation
Time frame: 1 year
Adverse events
Number of patients with adverse events
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.