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NOT YET RECRUITING
NCT07231523
PHASE3

EFG vs IVIG in TAMG

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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