UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002563 |
|---|---|
| Receipt number | 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 13:54:37 |
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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
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
tomo0204@yahoo.co.jp
Sponsor or person
Institute
Hyogo College of Medicine hepatobiliary and pancreas internal medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003132
