An Open Study for Steroid Resistant, Non-Thymectomized MG... | NCT00309101

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

NCT00309101

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jun 3, 2009Estimated

Enrollment

11Actual

Phase

Phase 3

Conditions

Myasthenia Gravis

Interventions

tacrolimus

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Mar 29, 2006

First Submission Date that Met QC Criteria

Mar 29, 2006

First Posted Date

Mar 31, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2009

Last Update Posted Date

Jun 3, 2009Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. tacrolimus	Experimental		Drug: tacrolimus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tacrolimus	Drug	Oral	1. tacrolimus	FK506 Prograf

Measure	Description	Time Frame
Improvement of clinical symptoms		28 Weeks

Measure	Description	Time Frame
Improvement of daily activity		28 Weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

64 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Central Contact	Astellas Pharma Inc	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D009157	Myasthenia Gravis

Ancestor Terms

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016559	Tacrolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Chubu Region			Japan