UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study for effectiveness of rituximab for acquired coagulopathy
Title of the study (Brief title)	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	Ogawa, Yoshiyuki
Organization	Gunma Unviersity
Division name	School of Medicine
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8166
Email	yo-ogawa@gunma-u.ac.jp

Public contact
Name of contact person	Ogawa, Yoshiyuki
Organization	Gunma Unviersity
Division name	School of Medicine
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8166
Homepage URL	http://ciru.dept.showa.gunma-u.ac.jp/
Email	yo-ogawa@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023676