drugset / Trial / NCT07231523
EFG vs IVIG in TAMG
Phase 3
Not yet recruiting
64 enrolled
Shanghai Zhongshan Hospital
First Affiliated Hospital of Wenzhou Medical University · collabHuashan Hospital · collabSecond Affiliated Hospital of Soochow University · collabTang-Du Hospital · collabThe Affiliated Brain Hospital of Nanjing Medical University · collabThe Affiliated Hospital of Xuzhou Medical University · collabThe First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWest China Hospital · collabWuhan TongJi Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-12-01
- Primary completion
- 2027-06-01
- Completion
- 2027-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efgartigimod Alfa | Protein / enzyme biologic | 10 mg/kg | — |
| Subject | Efgartigimod Alfa | Protein / enzyme biologic | 1200 mg | — |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 400 mg/kg | Intravenous |