UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot Study Evaluating the efficacy and safety of Polymyxin B-immobilized Fiber Column (PMX) Hemoperfusion Treatment for Idiopathic Pulmonary Fibrosis with Acute Exacerbation
Title of the study (Brief title)	Pilot Study Evaluating the efficacy and safety of Polymyxin B-immobilized Fiber Column (PMX) Hemoperfusion Treatment for Idiopathic Pulmonary Fibrosis with Acute Exacerbation
Region	Japan

Condition
Condition	Idiopathic pulmonary fibrosis
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy and safety when a PMX treatment is added to the conventional medication (a steroid massive dose therapy, a neutrophil elastase inhibitory drug, and the combined therapy of an immunosuppressant) for the patient with acute idiopathic pulmonary fibrosis exacerbation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- A survival rate after four weeks from the PMX treatment - Adverse Events occurred during follow-up period after PMX treatment
Key secondary outcomes	- Effect of PMX on P/F after one week from the PMX treatment - Effect of PMX on radiological image after one/four weeks from the PMX treatment - Effect of PMX on CRP in serum after one week from the PMX treatment - Effect of PMX on radiological image after four/twelve weeks from the PMX treatment - duration of mechanical ventilation - A survival rate after twelve weeks from the PMX treatment

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	Device,equipment
Interventions/Control_1	Patients treated with Toraymyxin
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) >= 20 and <=80 years of age 2) able and willing to provide informed consent. 3) meet all of the following inclusion criteria within one month; - increasing dyspnea - Frosted glass shadow, the permeation shadow which occurred in addition to a honeycomb lungs lesion with a chest image newly - decreasing PaO2 4) PF ratio <300 5) undergone PMX treatment before enrollment
Key exclusion criteria	1) pregnant or lactating 2) history of hypersensitivity for blood purification or Extracorporeal circulation therapy 3) participated in another clinical research of non-approved medical device or drug , or has not passed the time of 5 times or more of the half-life in blood of a non-approved drug after the end of non-approved drug medication 4) difficulty in evaluation of this study; terminal cancer, chronic renal failure, the death within seven days are predicted 5) endotoxin blood symptom 6) respiratory infection, pneumothorax, pulmonary embolism, or heart failure 7) considered ineligible for the study by the investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroki Hayashi
Organization	Nippon Medical School Hospital
Division name	Department of Pulmonary Medicine
Address	1-1-5 Sendagi, bunkyo-ku, Tokyo
TEL	03-5685-3075
Email	s5075@nms.ac.jp

Public contact
Name of contact person	Hiroki Hayashi
Organization	Nippon Medical School Hospital
Division name	Department of Pulmonary Medicine
Address	1-1-5 Sendagi, bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	s5075@nms.ac.jp

Sponsor
Institute	Nippon Medical School Hospital
Institute
Department

Funding Source
Organization	MHLW Research Grant
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kanagawa Cardiovascular and Respiratory Center
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	日本医科大学付属病院(東京都)、神奈川県立循環器呼吸器病センター(神奈川県)

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 23 Day
Anticipated trial start date	2014 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 10 Day
Last modified on	2019 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015302