UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007387 |
|---|---|
| Receipt number | R000008704 |
| Scientific Title | Clinical trials for long-term administration of sirolimus for lymphangioleiomyomatosis |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2020/03/04 09:27:01 |
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Basic information
Public title
Clinical trials for long-term administration of sirolimus for lymphangioleiomyomatosis
Acronym
Long-term administration of sirolimus for lymphangioleiomyomatosis
Scientific Title
Clinical trials for long-term administration of sirolimus for lymphangioleiomyomatosis
Scientific Title:Acronym
Long-term administration of sirolimus for lymphangioleiomyomatosis
Region
| Japan |
Condition
Condition
lymphangioleiomyomatosis
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety with long-term administration of sirolimus for lymphangioleiomyomatosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Symptoms, respiratory function, presence or absence of side effects after two years of administration
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sirolimus
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
Female
Key inclusion criteria
patients with lymphangioleiomyomatosis
Key exclusion criteria
pregnancy
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | yoshihiro |
| Middle name | |
| Last name | Nishimura |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratiry Medicine
Zip code
6512102
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5668
nishiy@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | yoshihiro |
| Middle name | |
| Last name | Nishimura |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratiry Medicine
Zip code
6512102
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5668
Homepage URL
nishiy@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Respiratiry Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Univ. Hospital Clinical Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
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
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
non
Publication of results
Unpublished
Result
URL related to results and publications
non
Number of participants that the trial has enrolled
1
Results
No adverse effects
Results date posted
| 2020 | Year | 03 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A LAM patient
Participant flow
NA
Adverse events
Nothing
Outcome measures
No adverse effects
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008704
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
