UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024612 |
|---|---|
| Receipt number | R000023676 |
| Scientific Title | Clinical study for effectiveness of rituximab for acquired coagulopathy |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2016/10/28 17:50:39 |
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Basic information
Public title
Clinical study for effectiveness of rituximab for acquired coagulopathy
Acronym
Rituximab Trial for acquired coagulopathy
Scientific Title
Clinical study for effectiveness of rituximab for acquired coagulopathy
Scientific Title:Acronym
Rituximab Trial for acquired coagulopathy
Region
| Japan |
Condition
Condition
acquired coagulopathy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness and safety of rituximab for acquired coagulopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disappearance of coagulation factor inhibitor on day 56 after rituximab administration
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
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rituximab
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who had a diagnosis of a hemorrhagic acquired coagulation disorder
Age at agreement acquisition is the patients 85 years or younger 20 years old or older.
About participation in this study, a document agreement is the obtained patients from person .
(4)
The patients who meet criteria of the following rituximab administration.
(1)
Recurrence, the intractable case that is refractory to steroid therapy
(2)
The patients that attending physitian judged that steroid use was not suitable for some reason by initial treatment.
The steroid unsuitable corresponds to following
a)
The patients that exacerbation is expected with mental cognitive impairment.
b)
The patients who had the diabetes mellitus inadequate control.
c)
The patients who have hemorrhagic gastric ulcer.
d)
In addition, the patients that attending physitian judged steroid use to be inadequate.
Key exclusion criteria
(1)
The men that an agreement is not obtained in preventing conception during study drug dosing period.
(2)
The women who may be pregnant during nursing during pregnancy and the women who hope for pregnancy during study drug dosing period.
(3)
The patients who are proved to have an HIV antibody.
(4)
The patients that positive was confirmed in one or more with HBs antigen, HBs antibody, anti-hepatitis B core antigen and HCV antibody.
(however, we do not do it with the subject of the exclusion by this rule when a thing with the vaccination is clear when an examination of hepatitis B is positive)
(5)
In addition, the patients whom doctor attending judged to be inadequate as an object of this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ogawa, Yoshiyuki |
Organization
Gunma Unviersity
Division name
School of Medicine
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8166
yo-ogawa@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ogawa, Yoshiyuki |
Organization
Gunma Unviersity
Division name
School of Medicine
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8166
Homepage URL
http://ciru.dept.showa.gunma-u.ac.jp/
yo-ogawa@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
| 2016 | Year | 11 | Month | 01 | 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
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | 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
| 2016 | Year | 10 | Month | 28 | Day |
Last modified on
| 2016 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023676
