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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Myasthenia Gravis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tacrolimus group

Group Type EXPERIMENTAL

Tacrolimus capsule

Intervention Type DRUG

oral

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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Tacrolimus capsule

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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Prograf FK506

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No