UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001716 |
|---|---|
| Receipt number | R000002058 |
| Scientific Title | A Phase I/II study of JR-031 for the patients of standard primary treatment-refractory acute graft-versus-host disease (acute GVHD) after hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2009/02/19 |
| Last modified on | 2012/11/22 10:30:41 |
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Basic information
Public title
A Phase I/II study of JR-031 for the patients of standard primary treatment-refractory acute graft-versus-host disease (acute GVHD) after hematopoietic stem cell transplantation
Acronym
A Phase I/II study of JR-031 for acute GVHD
Scientific Title
A Phase I/II study of JR-031 for the patients of standard primary treatment-refractory acute graft-versus-host disease (acute GVHD) after hematopoietic stem cell transplantation
Scientific Title:Acronym
A Phase I/II study of JR-031 for acute GVHD
Region
| Japan |
Condition
Condition
Standard primary treatment-refractory acute GVHD
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of JR-031 for standard primary treatment-refractory acute GVHD after allogenic hematopoietic stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Effectiveness of GVHD treatment from the first dose point to 4 weeks later and others
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
*JR-031
*First dose within 48 hours after the diagnosis and 8 divided doses for 4 weeks for the participants who was diagnosed as standard treatment refractory acute GVHD.
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
| 6 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*GradeII-IV of acute GVHD (the guideline of JSHCT).
*Standard treatment-refractory acute GVHD.
*Age => 6 months
Key exclusion criteria
*Patients who had the acute GVHD therapy except standard therapy with corticosteroids.
*Patients who had the hematopoietic transplantation while their malignant disease was not remitted (except for the patients who have little possibility of early relapse).
*Oxygen gas saturation in rest < 94%.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiya Ozawa |
Organization
Jichi Medical University
Hospital
Division name
Division of Hematology
Zip code
Address
3311-1 Yakushi-ji, Shimotsuke-shi, Tochigi, 329-0498, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
JCR pharmaceuticals Co., Ltd.
Division name
Research and Development div.
Zip code
Address
2-4 Kasuga-cho, Ashiya 659-0021 Japan
TEL
0797-32-8582
Homepage URL
Sponsor or person
Institute
JCR pharmaceuticals Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
JCR pharmaceuticals Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 02 | Month | 19 | 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
| 2008 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 19 | Day |
Last modified on
| 2012 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002058
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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