UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014969 |
|---|---|
| Receipt number | R000017414 |
| Scientific Title | Single Arm Open Labeled Multicenter Trial for Safety and Efficacy of recombinant human soluble Thrombomodulin for Acute Exacerbation of Idiopathic Interstitial pneumonias |
| Date of disclosure of the study information | 2014/08/28 |
| Last modified on | 2020/06/13 16:51:32 |
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Basic information
Public title
Single Arm Open Labeled Multicenter Trial for Safety and Efficacy of recombinant human soluble Thrombomodulin for Acute Exacerbation of Idiopathic Interstitial pneumonias
Acronym
Trial for Safety and Efficacy of Thrombomodulin for Acute Exacerbation of Idiopathic Interstitial Pneumonias (SETUP Trial)
Scientific Title
Single Arm Open Labeled Multicenter Trial for Safety and Efficacy of recombinant human soluble Thrombomodulin for Acute Exacerbation of Idiopathic Interstitial pneumonias
Scientific Title:Acronym
Trial for Safety and Efficacy of Thrombomodulin for Acute Exacerbation of Idiopathic Interstitial Pneumonias (SETUP Trial)
Region
| Japan |
Condition
Condition
Acute exacerbation of idiopathic interstitial pneumonias
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of recombinant human soluble thrombomodulin for acute exacerbation of chronic idiopathic interstitial pneumonias
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
90 days survival compared with cases of acute exacerbation of idiopathic interstitial pneumonias treated in the past.
Key secondary outcomes
Changes of serum markers, coagulation markers, arterial blood gas analysis and HRCT findings after the start of thrombomodulin are observed. Occurrence of bleeding and frequency of positive pressure ventilation are compared with control.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention: recombinant soluble human thrombomodulin
Control: Cases of acute exacerbation of idiopathic interstitial pneumonias treated in the past
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
Cases of acute exacerbation of chronic idiopathic interstitial pneumonias.
Key exclusion criteria
1) Patients with major organ dysfunction.
2) Patients with fatal bleeding including intracranial bleeding, bleeding from gastrointestinal tracts, lung hemorrhage and so on.
3) Patients with high probability of fatal bleeding.
4) Patients with cerebral vascular diseases within one year.
5) Patients with intracranial damage caused by operations and external injury.
6) Pregnant or lactating woman, and woman with possibility of pregnancy.
7) Patients with apparent infection.
8) Patients within one month after surgery.
9) Patients with past history of hypersensitivity to thrombomodulin.
10) Patients improper to the trial according to the decision of a chief doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Inoue |
Organization
NHO Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
591-8555
Address
1180 Ngasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL
072-252-3021
inoue.yoshikazu.nt@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Arai |
Organization
NHO Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
591-8555
Address
1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL
072-252-3021
Homepage URL
arai.toru.cp@mail.hosp.go.jp
Sponsor or person
Institute
NHO Kinki-Chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review board of NHO Kinki-Chuo Chest Medical Center
Address
1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan
Tel
072-252-3021
agata.yuka.zd@mail.hosp.go.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
大阪大学大学院医学研究科呼吸器・免疫内科（大阪府）
大阪府立病院機構大阪はびきの医療センター（大阪府）
田附興風会北野病院（大阪府）
堺市立総合医療センター（大阪府）
大阪警察病院（大阪府）
市立岸和田市民病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/resp.13514
Number of participants that the trial has enrolled
Results
The 90-day survival rates of AE-IIP patients treated with/without rhTM were 66.7% (26/39) and 47.5% (29/61), respectively. rhTM therapy was significantly associated with reduced mortality (adjusted hazard ratio: 0.453; 95% CI: 0.237-0.864; P=0.0163) by IPTW. Frequency of adverse events was identical in two arms. Two bleeding events occurred in rhTM arm.
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
| 2014 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 07 | Month | 17 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 27 | Day |
Last modified on
| 2020 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017414
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/06/20 | SETUP trial protocol KCCMC.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/06/13 | SETUP Trial Case Card 20140715 3PDF.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/06/13 | SETUP 20170305 1 20180717 2 SPSS to Edahiro.xlsx |
