UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of recombinant human soluble thrombomodulin for acute exacerbation of idiopathic pulmonary fibrosis.
Title of the study (Brief title)	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	Yasuo Matsuzawa
Organization	Toho university
Division name	Division of Pneumology
Address	564-1 Shimoshizu Sakura City, Chiba Prefecture 285-8741
TEL
Email

Public contact
Name of contact person	Yasuo Matsuzawa
Organization	Toho university
Division name	Division of Pneumology
Address	564-1 Shimoshizu Sakura City, Chiba Prefecture 285-8741
TEL	043-462-8811
Homepage URL
Email	yasuo23@sakura.med.toho-u.ac.jp

Sponsor
Institute	Toho university
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 09 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010655