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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003147
Receipt No. 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

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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
Email 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
Email kaji6485@yokohama-cu.ac.jp

Sponsor
Institute Yokohama city university hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003818

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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