|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02159651 |
|
Date of registration:
|
06/06/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia
|
|
Scientific title:
|
Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis |
|
Date of first enrolment:
|
April 1, 2014 |
|
Target sample size:
|
179 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02159651 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Medical Director |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Astellas Pharma Inc |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Hospitalized patient
- Patient diagnosed with Interstitial pneumonia associated with
polymyositis/dermatomyositis
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
|
|
Intervention(s)
|
|
Drug: tacrolimus
|
|
Primary Outcome(s)
|
|
Overall survival
[Time Frame: Up to three years]
|
|
Secondary Outcome(s)
|
|
Arterial blood gas analysis value (PaO2, AaDO2)
[Time Frame: Up to three years]
|
|
Chest CT findings
[Time Frame: Up to three years]
|
|
Patient disposition
[Time Frame: Up to three years]
|
|
Respiratory function test value (%FVC, %DLco)
[Time Frame: Up to three years]
|
|
Safety assessed by the incidence of adverse events
[Time Frame: Up to three years]
|
|
Serum KL-6 value (serum SP-D value)
[Time Frame: Up to three years]
|
|
Secondary ID(s)
|
|
506-MA-PRGI-01
|
|
PRGI01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|