UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Oral Beclometasone dipropionate for for gut GVHD
Title of the study (Brief title)	BDP for gut GVHD
Region	Japan

Condition
Condition	Gut Graft-versus-host disease
Classification by specialty	Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety for gut GVHD to avoid the side effect of systemic steroid treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Efficacy for upper/lower digestive symptom at four months after treatment by NIH GVHD response criteria
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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	oral beclometasone treatment for four months
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	11 years-old <=
Age-upper limit	11 years-old >=
Gender	Male
Key inclusion criteria	a pediatric case with steroid dependent gut gVHD
Key exclusion criteria	no active cytomegalovirus (CMV) infection and no CMV antigenemia for confirmed endoscopically gut GVHD
Target sample size	1

Research contact person
Name of lead principal investigator	Satoru Hamada
Organization	University of Ryukyus, hospital
Division name	Department of Pediatrics
Address	207 Uehara, Nishihara, Okinawa
TEL	0988953331
Email	shamada@med.u-ryukyu.ac.jp

Public contact
Name of contact person	Satoru Hamada
Organization	University of Ryukyus, hospital
Division name	Department of Pediatrics
Address	207 Uehara, Nishihara, Okinawa
TEL	0988953331
Homepage URL
Email	shamada@med.u-ryukyu.ac.jp

Sponsor
Institute	Department of Pediatrics, University of Ryukyus, hospital
Institute
Department

Funding Source
Organization	Department of Pediatrics, University of Ryukyus, hospital
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2018 Year 03 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 03 Month 15 Day
Anticipated trial start date	2018 Year 03 Month 15 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	2018 Year 03 Month 13 Day
Last modified on	2018 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036207