UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021928
Receipt number R000025282
Scientific Title The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen
Date of disclosure of the study information 2016/04/15
Last modified on 2023/03/11 10:09:18

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Basic information

Public title

The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen

Acronym

The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen

Scientific Title

The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen

Scientific Title:Acronym

The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen

Region

Japan


Condition

Condition

H. pylori-positve patients after the 2nd line eradication failure

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of 7-day regimen with RBT, AMPC and Pcab.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The efficacy of H. pylori eradication

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

vonoprazan 40mg, b.i.d., amoxicillin 2.0g, q.i.d., rifabutin 300mg, o.d.
7 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

H. pylori-positve patients after the 2nd line H. pylori eradication therapy with informed consent

Key exclusion criteria

1. Patients with allergy for rifamycins
2. Patients with past histry of tuberculosis or nontuberculous mycobacterial infection
3. Patients with allergy for PPIs
4. Patients with allergy for penicillin
5. Patients with severe liver injury and/or severe renal damage
6. Pregnancy or possible pregnancy
7. Patients who are taking voriconazole
8. Patients with uveitis
9. Patients who were recognized as inappropriate for entry

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Tastuhiro
Middle name
Last name Masaoka

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

160-0016

Address

35 Shinanomachi, SHinjuku-ku, Tokyo

TEL

03-5363-3790

Email

masaoka@z6.keio.jp


Public contact

Name of contact person

1st name Tastuhiro
Middle name
Last name Masaoka

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

160-0016

Address

35 Shinanomachi, SHinjuku-ku, Tokyo

TEL

03-5363-3790

Homepage URL


Email

masaoka@z6.keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

other

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Planning and Management Office Clinical and Translational Research Center.

Address

35 Shinanomachi, SHinjuku-ku, Tokyo

Tel

03-5363-3961

Email

pmo@ccr.med.keio.ac.jp


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

2016 Year 04 Month 15 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/35644041/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35644041/

Number of participants that the trial has enrolled

66

Results

Intention-to-treat and per-protocol analyses showed that our regimen resulted in a high eradication rate (91.2%, 95% CI: 84%-99% and 92.7%, 95% CI: 86%-100%, respectively). Adverse events occurred in 31.6% of the patients, and two patients discontinued the therapy.

Results date posted

2023 Year 03 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients who did not respond to second-line therapy were enrolled. After H. pylori infection was confirmed with the culture method, the patients received rifabutin-containing triple therapy (20 mg vonoprazan b.i.d., 500 mg amoxicillin q.i.d., and 150 mg rifabutin q.d.) for 7 days.

Participant flow

Patients who did not respond to second-line therapy were enrolled. After H. pylori infection was confirmed with the culture method, the patients received rifabutin-containing triple therapy (20 mg vonoprazan b.i.d., 500 mg amoxicillin q.i.d., and 150 mg rifabutin q.d.) for 7 days.

Adverse events

Adverse events occurred in 31.6% of the patients, and two patients discontinued the therapy.

Outcome measures

Twelve weeks after the eradication therapy, successful eradication was confirmed using a 13 C urea breath test or the H. pylori stool antigen test. The results obtained from our previous study that reported a 10-day or 14-day esomeprazole based rifabutin-containing triple therapy as a third- or fourth-line rescue therapy treated patients were used as historical control. We determined the minimum inhibitory concentrations of amoxicillin and rifabutin. We also evaluated whether the patients were positive for the mutation of the rpoB gene.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 02 Month 04 Day

Date of IRB

2016 Year 04 Month 15 Day

Anticipated trial start date

2016 Year 04 Month 15 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 15 Day

Last modified on

2023 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025282


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name