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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023357
Receipt No. 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

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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
Email 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
Email susumu1029@gmail.com

Sponsor
Institute Division of Respiratory Medicine, Toho University Omori Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026912

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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