UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety, efficacy and the predictive factors of efficacy of beclomethasone dipropionate (BDP) for acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation
Title of the study (Brief title)	The safety, efficacy and the predictive factors of efficacy of BDP for acute GVHD
Region	Japan

Condition
Condition	Hematologic disorders gastrointestinal acute GVHD
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of oral BDP for gastrointestinal acute GVHD and to identify factors of predicting efficacy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	The complete response rate of gastrointestinal acute GVHD at day28 after starting treatment
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 Other
Interventions/Control_1	BDP treatment for gastrointestinal acute GVHD. Both plain gelatin and enteric-coated gelatin capsule of hospital preparation are manufactured by filling 1mg BDP in the pharmaceutical department of our institution. Patients will receive one uncoated and one enteric- coated capsule orally four times a day.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with biopsy-proven or clinically strongly suspected gastrointestinal acute GVHD and with symptoms (including nausea or vomiting without >=500ml of diarrhea/day) and with inadequate oral intake (<70% of daily caloric requirements)
Key exclusion criteria	1. Patients requiring systemic steroid treatment for grade 2 acute GVHD of skin and/or liver 2. Patients who cannot intake oral BDP 3. Uncontrollable infection in the gastrointestinal tract 4. Pregnant or possibility pregnant woman 5. Inappropriate to participate in this study as judged by the physician in charge
Target sample size	26

Research contact person
Name of lead principal investigator	Masayuki Hino
Organization	Graduate School of Medicine, Osaka City University
Division name	Hematology
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL	06-6645-3881
Email	hinom@med.osaka-cu.ac.jp

Public contact
Name of contact person	Mitsutaka Nishimoto
Organization	Graduate School of Medicine, Osaka City University
Division name	Hematology
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL	06-6645-3881
Homepage URL
Email	nishimo@med.osaka-cu.ac.jp

Sponsor
Institute	Hematology,Graduate School of Medicine, Osaka City University
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)

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	2012 Year 03 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 05 Day
Anticipated trial start date	2012 Year 03 Month 07 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	2012 Year 03 Month 05 Day
Last modified on	2019 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008699