UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013116
Receipt number R000015302
Scientific Title Pilot Study Evaluating the efficacy and safety of Polymyxin B-immobilized Fiber Column (PMX) Hemoperfusion Treatment for Idiopathic Pulmonary Fibrosis with Acute Exacerbation
Date of disclosure of the study information 2014/02/10
Last modified on 2019/02/15 20:22:05

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Basic information

Public title

Pilot Study Evaluating the efficacy and safety of Polymyxin B-immobilized Fiber Column (PMX) Hemoperfusion Treatment for Idiopathic Pulmonary Fibrosis with Acute Exacerbation

Acronym

Pilot Study Evaluating the efficacy and safety of Polymyxin B-immobilized Fiber Column (PMX) Hemoperfusion Treatment for Idiopathic Pulmonary Fibrosis with Acute Exacerbation

Scientific Title

Pilot Study Evaluating the efficacy and safety of Polymyxin B-immobilized Fiber Column (PMX) Hemoperfusion Treatment for Idiopathic Pulmonary Fibrosis with Acute Exacerbation

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroki Hayashi

Organization

Nippon Medical School Hospital

Division name

Department of Pulmonary Medicine

Zip code


Address

1-1-5 Sendagi, bunkyo-ku, Tokyo

TEL

03-5685-3075

Email

s5075@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Hayashi

Organization

Nippon Medical School Hospital

Division name

Department of Pulmonary Medicine

Zip code


Address

1-1-5 Sendagi, bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

s5075@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

2013 Year 10 Month 23 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015302


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name