UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory clinical trial of the new 4th line Helicobacter pylori eradication therapy using vonoprazan
Acronym	Efficacy of the new salvage line Helicobacter pylori eradication therapy using vonoprazan
Scientific Title	Exploratory clinical trial of the new 4th line Helicobacter pylori eradication therapy using vonoprazan
Scientific Title:Acronym	Efficacy of the new salvage line Helicobacter pylori eradication therapy using vonoprazan
Region	Japan

Condition
Condition	Helicobacter infection with previous eradication failure
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of the new third line therapy using vonoprazan
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Eradication rate of Helicobacter pylori 8-12 wks after treatment
Key secondary outcomes	Rate of adverse events

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	Vonoprazan 20mg bid Amoxicillin 750mg bid Rifabutin 150mg bid
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with three eradication failures by clarithromycin, metronidazole and sitafloxacin based regimen
Key exclusion criteria	Pregnancy Lactation Allergy for the study drugs Severe major organ dysfunction Patients who are judged by the investigators to be inappropriate for this study
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Atsuo Yamada
Organization	The University of Tokyo
Division name	Department of Gastroenterology
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-3815-5411
Email	yamada-a@umin.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Atsuo Yamada
Organization	The University of Tokyo
Division name	Department of Gastroenterology
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-3815-5411
Homepage URL
Email	yamada-a@umin.ac.jp

Sponsor
Institute	Department of Gastroenterology, The University of Tokyo
Institute
Department

Funding Source
Organization	Department of Gastroenterology, The University of Tokyo
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
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	2015 Year 09 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	Completed
Date of protocol fixation	2015 Year 07 Month 30 Day
Date of IRB	2015 Year 08 Month 04 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2019 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 27 Day
Last modified on	2019 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021740