Status:
COMPLETED
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
16-64 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.
Eligibility Criteria
Inclusion
- Clinically diagnosed as myasthenia gravis
- Those whose MG symptoms are well-controlled by the treatment with prednisone
- Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain
Exclusion
- Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
- Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug
- Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.
- Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.
- Pancreatitis or diabetes
- Serum creatinine≦1.5mg/dL
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00309088
Start Date
April 1 2006
End Date
June 1 2008
Last Update
August 25 2014
Active Locations (9)
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1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Hokuriku Region, Japan