An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

NCT ID: NCT00309101

Last Updated: 2009-06-03

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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-02-28

Brief Summary

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The purpose of the study is to investigate the efficacy and safety for steroid resistant, non-thymectomized MG patients.

Detailed Description

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Conditions

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Myasthenia Gravis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. tacrolimus

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

Oral

Interventions

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tacrolimus

Oral

Intervention Type DRUG

Other Intervention Names

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FK506 Prograf

Eligibility Criteria

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Inclusion Criteria

* Clinically diagnosed as myasthenia gravis
* Those whose MG symptoms are not controlled by the treatment with prednisone

Exclusion Criteria

* Those who had undergone thymectomy
Minimum Eligible Age

16 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma, Inc

Principal Investigators

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Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Chubu Region, , Japan

Site Status

Chugoku Region, , Japan

Site Status

Hokkaido Region, , Japan

Site Status

Hokuriku Region, , Japan

Site Status

Kansai Region, , Japan

Site Status

Kanto Region, , Japan

Site Status

Kyushu Region, , Japan

Site Status

Shikoku Region, , Japan

Site Status

Tohoku Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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F506-CL-0602

Identifier Type: -

Identifier Source: org_study_id

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