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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009730
Receipt No. 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

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

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
URL(English) https://upload.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


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