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The effectiveness and safety of using Vyvgart in the perioperative period of MG thymectomy patients

The effectiveness and safety of using Vyvgart in the perioperative period of MG thymectomy patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087638
Enrollment
Unknown
Registered
2024-07-31
Start date
2023-11-24
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia gravis

Interventions

Retrospective control group (Thymectomy was performed after blood filtration/immunoglobulin therapy):None
experimental group:Vyvgart is administered at a dose of 10mg/kg, 1-2 times before undergoing thymectomy surgery.

Sponsors

Shijiazhuang People’s Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 and above; 2) According to the evaluation of the thoracic surgery or neurology physicians at our center, MGFA is classified as a type IIb-IVb patient with myasthenia gravis; 3) MG patients who undergo thymectomy on a scheduled basis have no contraindications for surgery or anesthesia; 4) For women with reproductive potential: agree to use appropriate contraceptive measures during treatment and at least 3 months after receiving the last dose of Egamode; 5) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1)Study subjects who are known to be allergic to any component of the investigational drug or any other anti neonatal FcRn drug; 2)According to the researcher's assessment, the study participants have clinically significant active infections (including untreated or insufficiently treated infections); 3)The total IgG level of the study subjects during screening visits is = 6 g/L 4)Patients with severe underlying diseases such as heart failure, arrhythmia, and coagulation dysfunction.

Design outcomes

Primary

MeasureTime frame
myasthenia gravis foundation of America;The proportion of patients who successfully underwent tracheal intubation within one day after thymic surgery and did not undergo tracheal intubation again within one week;

Secondary

MeasureTime frame
activities of daily living;Quantitative Myasthenia Gravis score;Changes in antibodies against myasthenia gravis;Changes in lymphocytes;Changes in IgG;

Countries

China

Contacts

Public ContactQi Guoyan

Shijiazhuang People’s Hospital

qiguoyan1106@sina.com+86 176 0311 9295

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026