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NOT YET RECRUITING
NCT06221501
PHASE2

Perioperative Efgartigimod for Thymoma and Myasthenia Gravis

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

It is evidenced that efgartigimod can rapidly and significantly improve the symptoms of myasthenia gravis. The global multicenter clinical trials hace confirmed that efgartigimod is safe and well tolerated. Few case reports showed that perioperative efgartigimod combined with thymectomy was safe and feasible. However, there was no sufficient data on safety and efficacy of this regimen in the treatment for patients with myasthenia gravis and thymomas. Therefore, this trial aims to evaluate the efficacy and safety of perioperative efgartigimod and thymectomy for patients with myasthenia gravis and thymomas.

Official title: Safety and Efficacy of Perioperative Efgartigimod Combined With Thymectomy for Thymoma and Myasthenia Gravis: A Prospective, Single-arm Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-02-01

Completion Date

2027-06-30

Last Updated

2024-01-24

Healthy Volunteers

No

Interventions

DRUG

Efgartigimod Alfa

Efgartigimod will be administered intravenously on Day (D)1, D8, D15, and D22 at a dose of 10 mg/kg according to the patient's weight (maximum infusion dose of 1200 mg) over approximately 1 hour for a total of 4 doses. Thymectomy will be performed on Day 9.