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Atorvastatin Combined With NAC Plus Romiplostim for Management of ITP
Sponsor: Peking University People's Hospital
Summary
This is a prospective, single-arm, open-lable, single-center study and we aimed to determine whether atorvastatin combined with N-acetyl-L-cysteine (NAC) plus romiplostim could induce sustained response off-treatment (SRoT) in adult patients with ITP following CS failure.
Official title: Atorvastatin Combined With N-Acetyl-L-Cysteine Plus Romiplostim for Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-06-01
Completion Date
2028-12-30
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
atorvastatin, NAC, and romiplostim
From Week 1 to Week 24, atorvastatin and NAC was administrated as the dose of 20mg qd and 400mg tid,respectively, and were discontinued at the end of Week 24. For romiplostim, the initial dose was 3 μg/kg per week. The weekly dose was adjusted based on platelet counts, with a maximum dose of 10 μg/kg per week, to maintain platelet levels within the range of 100-200×10⁹/L during the initial 24-week period. From Week 25 to Week 35, romiplostim was gradually tapered and discontinued with the goal of maintaining a platelet count ≥30×10⁹/L and no less than twice the baseline level. After all medications (including atorvastatin, NAC, and romiplostim) were discontinued (no later than Week 36), patients were followed up for an additional 24 weeks to evaluate the sustained response rate at 24 weeks post-treatment cessation.
Locations (1)
Peking University People's Hospital
Beijing, China