UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012196 |
|---|---|
| Receipt number | R000013206 |
| Scientific Title | The Study on HElicobacter Pylori eradication in patients with HEPatic complications |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2016/11/09 11:21:35 |
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Basic information
Public title
The Study on HElicobacter Pylori eradication in patients with HEPatic complications
Acronym
HepHep Study
Scientific Title
The Study on HElicobacter Pylori eradication in patients with HEPatic complications
Scientific Title:Acronym
HepHep Study
Region
| Japan |
Condition
Condition
Chronic liver diseases
H. pylori infection
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether eradication of H. pylori in patients with chronic liver disease affects the hepatic complications such as thrombocytopenia and hyperammonemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in platelet counts after eradication of H. pylori
Key secondary outcomes
Changes in blood ammonia levels after eradication of H. pylori
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
Patients will orally receive triple therapy with 30mg lansoprazole, 750mg amoxicillin, and 250mg clarithromycin twice a day for seven days
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
1. Patients with chronic liver diseases
2. Patients with hepatic complications such as thrombocytopenia and hyperammonemia
3. Patients with H. pylori-related atrophic gastritis other upper gastrointestinal diseases diagnosed endoscopy
Key exclusion criteria
1. Patients with history of hypersensitivity to lansoprazole, amoxicillin, and clarithromycin.
2. Patients being treated with atazanavir, rilpivirine, pimozide, preparation containing ergotamine and tadalafil.
3. Patients with liver or kidney diseases being treated with colchicine.
4. Patients with infectious mononucleosis.
5. Patients with severe renal impairment.
6. Woman during the first three months of pregnancy.
7. Patients whom the principal and/or sub-investigators judged inadequate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Enomoto |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3811
enomoto-m@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Enomoto |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3811
Homepage URL
enomoto-m@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
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
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
| 2019 | Year | 03 | Month | 31 | 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
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 05 | 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
| 2013 | Year | 11 | Month | 01 | Day |
Last modified on
| 2016 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013206
