UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017738 |
|---|---|
| Receipt number | R000020548 |
| Scientific Title | An exploratory study of administration of Etanercept for patients with idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell trasnplantation |
| Date of disclosure of the study information | 2015/05/29 |
| Last modified on | 2020/06/01 16:50:36 |
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Basic information
Public title
An exploratory study of administration of Etanercept for patients with idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell trasnplantation
Acronym
Etanercept for IPS after allogeneic HSCT
Scientific Title
An exploratory study of administration of Etanercept for patients with idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell trasnplantation
Scientific Title:Acronym
Etanercept for IPS after allogeneic HSCT
Region
| Japan |
Condition
Condition
idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of etanercept for IPS after hematopoietic stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
withdrawal rate from oxygenation
Key secondary outcomes
1-year overall survival
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
Subcutaneous administration of etanercept, 0.4 mg/kg (max 25 mg) 2 times a week for four weeks.
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
(1) Patients who have received allogeneic hematopoietic stem cell transplantation.
(2) Patients with IPS.
NIH criteria for IPS
(a) multilobar infiltrates on CXR or CT.
(b) Clinical signs of pneumonia: cough, dyspnea, or rales.
(c) Abnormal physiology: increased arterial-alveolar oxygen gradient, or the need
for supplemental oxygen support.
(d) Negative BAL for bacterial and nonbacterial organisms.
(e) Negative surgical lung biopsy.
(a), (b) and (c) were all fulfilled and (d) or (e) was also fulfilled.
(3) patients equal or older than 20 yo.
(4) written informed consent was obtained.
Key exclusion criteria
(1) patients without enough .
(2) the presence of any of the following after at the time of enrollment.
(a) an active pulmonary infection as determined by positive culture of bronchoalveolar lavage (BAL) fluid.
(b) hypotension in which inotropic support other than dopamine was required.
(c) bacteremia within 48 hours before study entry.
(d) CMV viremia.
(e) systemic fungal or other nonbacterial
infections.
(f) clinical or echocardiographic evidence for cardiac dysfunction as the cause of respiratory failure.
(3) pregnancy or lactating.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Honda |
Organization
Univesity of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
ahonda-spr@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Honda |
Organization
Univesity of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
ahonda-spr@umin.org
Sponsor or person
Institute
Univesity of Tokyo Hospital,
Department of Hematology and Oncology
Institute
Department
Personal name
Funding Source
Organization
None.
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 29 | 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
| 2009 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020548
