UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027912 |
|---|---|
| Receipt number | R000031973 |
| Scientific Title | Sirolimus for treatment of bronchial stenosis after lung transplantation |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/12/27 22:42:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Sirolimus for treatment of bronchial stenosis after lung transplantation
Acronym
Sirolimus for post-lung transplant bronchial stenosis
Scientific Title
Sirolimus for treatment of bronchial stenosis after lung transplantation
Scientific Title:Acronym
Sirolimus for post-lung transplant bronchial stenosis
Region
| Japan |
Condition
Condition
Bronchial stenosis after lung transplantation
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy and the safety siroliums for treatment of bronchial stenosis after lung transplantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevention of recurrent bronchial stenosis
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
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Post-lung transplant patients with recurrent bronchial stenosis after lung transplantation who need conventional treatment every 3 months
Key exclusion criteria
- Patients with past-history of bronchial anastomosis dehiscence
- Patients with interstitial pneumonia or malignancy or delayed bronchial anastomosis healing
- Post- single lung transplant patients for interstitial pneumonia
- Patients in pregnancy or lactation
- Patients who want to be pregnant
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Oishi |
Organization
Tohoku University Hospital
Division name
Thoracic Surgery
Zip code
980-8575
Address
1-1 Seiryomachi, Aobaku, Sendai 980-8575 Japan
TEL
0227178521
hisashi.oishi.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Oishi |
Organization
Tohoku University Hospital
Division name
Thoracic Surgery
Zip code
980-8575
Address
1-1 Seiryomachi, Aobaku, Sendai 980-8575 Japan
TEL
08016676364
Homepage URL
hisashi.oishi.c7@tohoku.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic Surgery, Tohoku University Hospital
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
Tohoku University Hospital Institutional Review Board
Address
4-1 Seiryo-machi Aobaku
Tel
+81227178521
hisashi.oishi.c7@tohoku.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
| 2017 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 18 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 18 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 18 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 24 | Day |
Last modified on
| 2020 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031973
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
