UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009730
Receipt number R000011406
Scientific Title The research of safety and liver dysfunction in IBD patients with HBV treated with immunomodulatory treatments.
Date of disclosure of the study information 2013/01/08
Last modified on 2014/07/08 19:46:24

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Basic information

Public title

The research of safety and liver dysfunction in IBD patients with HBV treated with immunomodulatory treatments.

Acronym

The research of safety and liver dysfunction in IBD patients with HBV treated with immunomodulatory treatments.

Scientific Title

The research of safety and liver dysfunction in IBD patients with HBV treated with immunomodulatory treatments.

Scientific Title:Acronym

The research of safety and liver dysfunction in IBD patients with HBV treated with immunomodulatory treatments.

Region

Japan


Condition

Condition

Inflammatory bowel disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the prevalence of HBV infection in IBD patients who have registered in our hospital from 2007 to 2012. We retrospectively evaluated the safety and risk factors for liver dysfunction in IBD patients with HBV infections with treated with immunomodulatory medications.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. The prevalence of HBV infection
The number of patients with HBsAg-positive
The number of patients with HBsAb-positive and/or HBcAb-positive
2. The safety of medications
The prevalence of liver dysfunction* related to HBV and HBV reactivation
*Liver dysfunction is defined as an increase of 1.5-2-fold the baseline value ALT.
**Reactivation of HBV is defined as an increase of >2000IU/ml plus liver dysfunction (as above).
*/**Loras et al. Gut 2010

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Inclusion criteria:
UC and CD were diagnosed based on radiologic, endoscopic and histopathologic criteria.

Key exclusion criteria

None

Target sample size

4500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shiro Nakamura

Organization

Hyogo College of Medicine

Division name

Department of Internal Medicine, Division of Lower Gastroenterology

Zip code


Address

1-1 Mukogawa-cho Nishinomiya-city Hyogo

TEL

0798-45-6663

Email

shiro@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoko Yokoyama

Organization

Hyogo College of Medicine

Division name

Department of Internal Medicine, Division of Lower Gastroenterology

Zip code


Address

Hyogo College of Medicine

TEL

0798-45-6111

Homepage URL


Email

yoko0502@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine, Department of Internal Medicine, Division of Lower Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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

2013 Year 01 Month 08 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

Open public recruiting

Date of protocol fixation

2007 Year 01 Month 04 Day

Date of IRB


Anticipated trial start date

2007 Year 01 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2013 Year 01 Month 08 Day

Last modified on

2014 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011406


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name