Drug Use Surveillance of Takecab for Supplement to Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Drug Use Surveillance of Takecab Tablets Supplement to Helicobacter Pylori Eradication

Conditions
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Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other

Intervention / Treatment
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* Drug: Vonoprazan
* Drug: Amoxicillin hydrate
* Drug: Clarithromycin
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vonoprazan 20 mg<br>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<br>* Vonoprazan tablets<br>* Other names: TAK-438;Drug: Amoxicillin hydrate<br>* Amoxicillin hydrate (potency)<br>Drug: Clarithromycin<br>* Clarithromycin (potency)<br>Drug: Metronidazole<br>* Metronidazole<br>|

What is the study measuring?
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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 |