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
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
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
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
