UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Study on HElicobacter Pylori eradication in patients with HEPatic complications
Title of the study (Brief title)	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	Masaru Enomoto
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Hepatology
Address	1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3811
Email	enomoto-m@med.osaka-cu.ac.jp

Public contact
Name of contact person	Masaru Enomoto
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Hepatology
Address	1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3811
Homepage URL
Email	enomoto-m@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013206