UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015019 |
|---|---|
| Receipt number | R000017472 |
| Scientific Title | Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIG |
| Date of disclosure of the study information | 2014/09/02 |
| Last modified on | 2014/09/02 11:29:33 |
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Basic information
Public title
Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIG
Acronym
Combined therapy for tacrolimus and IVIG
Scientific Title
Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIG
Scientific Title:Acronym
Combined therapy for tacrolimus and IVIG
Region
| Japan |
Condition
Condition
Myasthenia gravis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate myasthenia gravis with high severity of early onset, started at the same time the IVIG and tacrolimus, performing this study to examine the context of patient can reach minimal manifestation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
QMG score and MGFA post-intervention status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tacrolimus and IVIG
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
MGFA class II-IV
QMG score 9<
Tensilon test positive
No indication for thymectomy
Key exclusion criteria
indication for thymectomy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kengo Fujita |
Organization
Kansai medical university
Division name
Neurology
Zip code
Address
Osaka pref. Hirakata city
TEL
072-804-0101
fujitake@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kengo fujita |
Organization
kansai medical univ.
Division name
neurology
Zip code
Address
Hirakata city
TEL
072-804-0101
Homepage URL
fujitake@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai medical university
Institute
Department
Personal name
Funding Source
Organization
Kansai medical university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 02 | Day |
Last modified on
| 2014 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017472
