UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003147 |
|---|---|
| Receipt number | R000003818 |
| Scientific Title | Cytokine (TNF alpha) blocking for acute and chronic graft versus host disease (GVHD) |
| Date of disclosure of the study information | 2010/02/12 |
| Last modified on | 2014/08/12 12:46:18 |
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Basic information
Public title
Cytokine (TNF alpha) blocking for acute and chronic graft versus host disease (GVHD)
Acronym
Cytokine blocking for GVHD
Scientific Title
Cytokine (TNF alpha) blocking for acute and chronic graft versus host disease (GVHD)
Scientific Title:Acronym
Cytokine blocking for GVHD
Region
| Japan |
Condition
Condition
Graft versus host disease (GVHD)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for clinical improvements by scoring data of symptoms and labolatory data, in the treatment for steroid dependence and refractory GVHD by etanercept.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of clinical GVHD score and improvement of labolatory data between before with after therapy.
Key secondary outcomes
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
Etanercept
0.4-1.0mg/ kg/ time (max 25mg)
Subcutaneous injection, total 8 weeks
Twice/ first 4 weeks, once/ last 4 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
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients received hematopoietic stem cell transplantation. And who diagnosed as steroid refractory or dependence GVHD. Who cannot receive conventional therapies for GVHD because of poor organ functions.
Refractory; No improvement by at least 6 days systemic steroid therapy.
Dependence; Need for over 20mg/day times 6 weeks steroid therapy.
Key exclusion criteria
1. sepsis, risk of sepsis
2. severe infection
3. active tuberculosis
4. anaphylactic episode of etanercept
5. demyelinating disease
6. congestive heart failure
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kajiwara Ryosuke |
Organization
Yokohama city university hospital
Division name
Pediatrics
Zip code
Address
3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
TEL
+81-45-787-2800
kaji6485@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kajiwara Ryosuke |
Organization
Yokohama city university hospital
Division name
Pediatrics
Zip code
Address
fukuura3-9, kanazawaku, yokohama
TEL
+81-45-787-2800
Homepage URL
kaji6485@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university hospital
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
| 2010 | Year | 02 | Month | 12 | 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
| 2010 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 08 | Day |
Last modified on
| 2014 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003818
