Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

Drug Use Surveillance of Takecab Tablets "Supplement to Helicobacter Pylori Eradication"

The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.

Study Overview

• Status: Completed
• Conditions: Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
• Intervention / Treatment: Drug: Vonoprazan; Drug: Amoxicillin hydrate; Drug: Clarithromycin; Drug: Metronidazole

Detailed Description

The drug being tested in this study is called Vonoprazan (Takecab). Vonoprazan is being tested to treat people who have gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis. This study will look at the presence or absence of new concerns regarding the safety of triple therapy with Vonoprazan tablets, amoxicillin, and clarithromycin (first-line eradication) and triple therapy with Vonoprazan tablets, amoxicillin, and metronidazole (second-line eradication) for supplemental Helicobacter pylori (H. pylori) eradication in the routine clinical setting. The study will enroll approximately 500 patients.

First-line eradication

• Vonoprazan 20 mg / Proton pump inhibitor
• Amoxicillin hydrate 750 mg
• Clarithromycin 200 mg

If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful.

Second-line eradication

• Vonoprazan 20 mg
• Amoxicillin hydrate 750 mg
• metronidazole 250 mg

This multi-center trial will be conducted in Japan.

• Study Type: Observational
• Enrollment (Actual): 560

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Takeda Selected Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will consist of participants receiving first-line eradication and second-line eradication including Takecab tablets (triple therapy) in the routine medical care.

Description

Inclusion Criteria:

• Participants receiving H. pylori eradication treatment for the first time
• Participants for whom H. pylori eradication with Takecab tablets or proton pump inhibitor + amoxicillin + clarithromycin was found unsuccessful and who will receive eradication treatment with amoxicillin and metronidazole

Exclusion Criteria:

• Participants with previous history of hypersensitivity to ingredients in Takecab tablets
• Participants taking atazanavir sulfate or rilpivirine hydrochloride

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Vonoprazan 20 mg; For adults, the following three-drug regimen will be administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400 mg (potency)/dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful, as an alternative treatment, the following three drugs will be administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants will receive interventions as part of routine medical care.

Drug: Vonoprazan; Vonoprazan tablets; Other Names: Takecab tablets; TAK-438; Drug: Amoxicillin hydrate; Amoxicillin hydrate (potency); Drug: Clarithromycin; Clarithromycin (potency); Drug: Metronidazole; Metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Had One or More Adverse Drug Reactions	Adverse drug reaction refers to adverse events related to administered drug. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).	Up to 7 days and 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H. Pylori Eradication Rate	In participants who were determined as achieving H. pylori eradication, the percentage of participants negative for H. pylori (eradication rates) was tabulated by first-line eradication and second-line eradication. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).	7 days + 2 months

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: December 25, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Autoimmune Diseases; Hematologic Diseases; Gastrointestinal Diseases; Stomach Diseases; Hemorrhage; Hemorrhagic Disorders; Gastroenteritis; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Blood Coagulation Disorders; Skin Manifestations; Thrombocytopenia; Blood Platelet Disorders; Lymphoma; Thrombotic Microangiopathies; Lymphoma, B-Cell; Gastritis; Purpura; Purpura, Thrombocytopenic; Lymphoma, B-Cell, Marginal Zone; Purpura, Thrombocytopenic, Idiopathic; Stomach Ulcer; Duodenal Ulcer; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Amoxicillin; Clarithromycin
• Other Study ID Numbers: Vonoprazan-5002; JapicCTI-153003 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No