A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma China, Inc.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• diagnosed as myasthenia gravis (MG) by clinical diagnosis

• QMG scores ≥7 at the time of enrollment

• basic treatment drugs are mainly glucocorticoids, and the efficacy of glucocorticoid therapy was not sufficient

Exclusion Criteria:

• receiving blood purification therapy or immunoglobulin therapy within 8 weeks before the study

• QMG swallowing function score ≥ 2 points or QMG vital capacity = 3

• abnormal hepatic functions

• uncontrolled diabetes patients

• hyperkalemia patients

• immuno-inhibitors are forbidden due to malignancy, history of malignancy or history of HIV infection

• patients who are allergic to Tacrolimus or macrolide antibiotics

• receiving other immuno-inhibitors within 12 weeks