UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009082 |
|---|---|
| Receipt number | R000010655 |
| Scientific Title | Efficacy of recombinant human soluble thrombomodulin for acute exacerbation of idiopathic pulmonary fibrosis. |
| Date of disclosure of the study information | 2012/10/10 |
| Last modified on | 2016/09/15 21:40:10 |
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Basic information
Public title
Efficacy of recombinant human soluble thrombomodulin for acute exacerbation of idiopathic pulmonary fibrosis.
Acronym
Efficasy of recombinant thrombomodulin for AE-IPF.
Scientific Title
Efficacy of recombinant human soluble thrombomodulin for acute exacerbation of idiopathic pulmonary fibrosis.
Scientific Title:Acronym
Efficasy of recombinant thrombomodulin for AE-IPF.
Region
| Japan |
Condition
Condition
acute exacerbation of idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to show the change of P/F ratio and D-dimer
of the patients with acute exacerbation of idiopathic pulmonary fibrosis, before and after 7days of administration of recombinant human soluble thrombomodulin and m-PSL pulse therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The change of P/F ratio before and after 7days of administration of recombinant human soluble thrombomodulin.
Key secondary outcomes
1.D-dimer value at the 1,4,8,15,29 hospital days.
2.P/F ratio at the 1,8,15,29 hospital days.
3.the survival rate at the 29 hospital days
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
The patients diagnosed as AE-IPF are treated with m-PSL pulse therapy and intravenous recombinant human soluble thrombomodulin (rhTM) within 24 hrs after the diagnosis.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to Toho Univercity
Sakura hospital and diagnosed AE-IPF based on the ATS/ERS/JRS guidelines
Key exclusion criteria
1)A person having an infection of apparent activity
2)Those who have apparent congestive heart failure.
3) Those who have apneumothorax
4) Those who have athma
5) Those who have deep vein thrombosis to be treated.
6) Who has the possibility of pulmonary arterial thromboembolism
7) A person who has circulatory failure, renal failure, liver failure
8) Those who have intracranial hemorrhage, pulmonary hemorrhage, gastrointestinal bleeding
9)A person with a history of hypersensitivity to components of the thrombomodulin
10) Women who may be pregnant or are pregnant
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Matsuzawa |
Organization
Toho university
Division name
Division of Pneumology
Zip code
Address
564-1 Shimoshizu Sakura City, Chiba Prefecture 285-8741
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Matsuzawa |
Organization
Toho university
Division name
Division of Pneumology
Zip code
Address
564-1 Shimoshizu Sakura City, Chiba Prefecture 285-8741
TEL
043-462-8811
Homepage URL
yasuo23@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 10 | Day |
Last modified on
| 2016 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010655
