To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis
who are inadequately treated by glucocorticoid.
Drug: Tacrolimus capsule
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Full eligibility criteria for NCT01325571
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
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
All locations for NCT01325571
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Tris trial is registered with FDA with number: NCT01325571. The sponsor of the trial is Astellas Pharma Inc and it is looking for 83 volunteers for the current phase.
Official trial title: A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy
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