UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023357 |
|---|---|
| Receipt number | R000026912 |
| Scientific Title | Recombinant Human Soluble Thrombomodulin for Acute Exacerbation of Idiopathic Pulmonary Fibrosis: A Historically Controlled Study |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/04/30 09:15:10 |
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Basic information
Public title
Recombinant Human Soluble Thrombomodulin for Acute Exacerbation of Idiopathic Pulmonary Fibrosis: A Historically Controlled Study
Acronym
rhTM for acute exacerbation of IPF
Scientific Title
Recombinant Human Soluble Thrombomodulin for Acute Exacerbation of Idiopathic Pulmonary Fibrosis: A Historically Controlled Study
Scientific Title:Acronym
rhTM for acute exacerbation of 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
To evaluate the effectiveness of rhTM for treatment of AE-IPF.The clinical features and outcomes (3-month, 6-month, overall survival) of 45 patients treated with rhTM (rhTM group) were compared with those of 35 patients who did not receive rhTM (control group).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
3-month survival
Key secondary outcomes
6-month, overall survival.
Safety of rhTM
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rhTM was administered intravenously (diluted in 100 mL of sterile saline) at a dose of 0.06mg/kg/day for the first 6 days, in combination with CS therapy.
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
(1) a previous or current diagnosis of IPF,
(2) unexplained worsening or development of dyspnea during the past 30 days,
(3) an HRCT scan showing new bilateral ground-glass opacities and/or consolidation superimposed on a background reticular or honeycomb pattern,
(4) no evidence of pulmonary infection on bronchoalveolar lavage, endotracheal aspiration, or sputum culture and negative results on blood tests for other potentially infectious pathogens (eg, pneumocystis jiroveci, cytomegalovirus), and
(5) exclusion of left heart failure, pulmonary embolism, and other possible causes of acute lung injury.
Key exclusion criteria
(1) coexisting life-threatening bleeding (pulmonary, gastrointestinal, or intracranial), history of cerebrovascular disorders during the previous 6 months, pregnancy, decompensated liver cirrhosis, and renal failure or other serious organ dysfunction.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sakae |
| Middle name | |
| Last name | Homma |
Organization
Toho University Omori Medical Center
Division name
Division of Respiratory Medicine
Zip code
143-8541
Address
Ota-ku Omori nisi 6-11-1, Tokyo 143-8541 (Japan)
TEL
+81337624151
susumu1029@gmail.com
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Sakamoto |
Organization
Toho University Omori Medical Center
Division name
Division of Respiratory Medicine
Zip code
143-8541
Address
Ota-ku Omori nisi 6-11-1, Tokyo 143-8541 (Japan)
TEL
+81337624151
Homepage URL
susumu1029@gmail.com
Sponsor or person
Institute
Division of Respiratory Medicine, Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Toho university omori medical center
Address
6-11-1 Omori-nishi Ohta-ku Tokyo Japan
Tel
0337624151
somu.omori@jim.toho-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
東邦大学医療センター大森病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
UMIN000023357
Publication of results
Published
Result
URL related to results and publications
000023357
Number of participants that the trial has enrolled
80
Results
3-month Survival rate improved in the TM administration group.
Results date posted
| 2019 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
median age 75 years. Male sex was 70 cases.
Participant flow
80 consecutive cases.We compared 35 cases of historical controll.
Adverse events
Mild hemoptysis and hematuria developed on the day after administration in one patients in the rhTM group.
Outcome measures
3-month survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 27 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026912
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
