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EFG vs IVIG in TAMG
Sponsor: Shanghai Zhongshan Hospital
Summary
This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the perioperative application for acetylcholine receptor (AChR) antibody-positive thymoma patients with myasthenia gravis in order to provide reliable evidence for clinical decision-making.
Official title: Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2025-12-01
Completion Date
2027-12-01
Last Updated
2025-11-17
Healthy Volunteers
No
Interventions
Efgartigimod + Thymectomy
Patients receive weight-based EFG infusions (10 mg/kg; fixed 1200 mg for ≥120 kg) administered over 1 hour once weekly for 4 total doses. If a scheduled infusion is missed, EFG may be administered within 48 hours of the planned time, followed by resumption of the original schedule to complete all 4 infusions. Thymectomy is performed on the day following the second EFG infusion with a permitted ±3-day surgical window.
Intravenous immunglobulin + Thymectomy
Patients receive weight-based IVIG infusions (400 mg/kg) administered daily for 5 consecutive days. Thymectomy is performed approximately 7 days after completing the final IVIG infusion, with a permitted ±3-day surgical window.
Locations (1)
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China