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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002563
Receipt No. R000003132
Scientific Title Examination of the utility of the Helicobacter pylori sanitization medical treatment in the chronic hepatitis C and liver cirrhosis
Date of disclosure of the study information 2009/10/01
Last modified on 2015/10/17

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Basic information
Public title Examination of the utility of the Helicobacter pylori sanitization medical treatment in the chronic hepatitis C and liver cirrhosis
Acronym Examination of the utility of the Helicobacter pylori sanitization medical treatment in the chronic hepatitis C and liver cirrhosis
Scientific Title Examination of the utility of the Helicobacter pylori sanitization medical treatment in the chronic hepatitis C and liver cirrhosis
Scientific Title:Acronym Examination of the utility of the Helicobacter pylori sanitization medical treatment in the chronic hepatitis C and liver cirrhosis
Region
Japan

Condition
Condition chronic hepatitis C and a cirrhosis of the liver patient
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For chronic hepatitis C and a cirrhosis of the liver patient, I examine a change of the sanitization blood platelet value by the type distinction of H.pylori to be able to put after curing and examine necessity of the H.pylori sanitization in the future liver disease patient
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examination according to the H.pylori cause of the disease factor seasonal polymorphism to have an influence on a change of the number of the blood platelets by the H.pylori sanitization medical treatment
Key secondary outcomes I divide blood platelet numerical value before sanitization into the high price group with low value group, and it is examined the number of the blood platelets improvement effect.
The examination of the change of the blood platelet numerical value in the interferon dosage patient.
Portal vein pressure sthenia symptom stomach symptom (PHG),an improvement effect of the gullet varication by the H.pylori sanitization medical treatment.

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
Interventions/Control_1 I inspect Helicobacter pylori by a serum antibody method.
It is omeprazole 20mg, amoxicillin 750mg, clarithromycin 400mg per day twice oral administration, one week for a Helicobacter pylori positive patient.
I do PPI rest medicine and I sanitize it by an urea breath test four weeks later and judge it.
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.The patient of the chronic hepatitis C and cirrhosis of the liver
2.The patient that I understand the contents of this study, and an agreement of the study participation is provided from the person himself by a document
Key exclusion criteria 1.The patient with a severe liver damage(Child-pugh classification GradeC)
2.In addition, the patient who judged the chief physician to be inappropriate as an object of this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name syuhei nishiguchi
Organization hyogo college of medicine
Division name hepatobiliary and pancreas internal medicine
Zip code
Address 1-1 mukogawa-cho nishinomiya hyogo
TEL 0798456474
Email tomo0204@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name tomoyuki takashima
Organization hyogo college of medicine
Division name hepatobiliary and pancreas internal medicine
Zip code
Address 1-1 mukogawa-cho nishinomiya hyogo
TEL 0798-45-6472
Homepage URL
Email tomo0204@yahoo.co.jp

Sponsor
Institute Hyogo College of Medicine hepatobiliary and pancreas internal medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization
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
2009 Year 10 Month 01 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
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 29 Day
Last modified on
2015 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003132

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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