UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007439
Receipt number R000008699
Scientific Title 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
Date of disclosure of the study information 2012/03/05
Last modified on 2019/01/18 10:21:59

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Basic information

Public title

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

Acronym

The safety, efficacy and the predictive factors of efficacy of BDP for acute GVHD

Scientific Title

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

Scientific Title:Acronym

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

1st name
Middle name
Last name Masayuki Hino

Organization

Graduate School of Medicine, Osaka City University

Division name

Hematology

Zip code


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

1st name
Middle name
Last name Mitsutaka Nishimoto

Organization

Graduate School of Medicine, Osaka City University

Division name

Hematology

Zip code


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 or person

Institute

Hematology,Graduate School of Medicine, Osaka City University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2012 Year 03 Month 05 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008699


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name