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

Takeda

Status: Completed

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

Treatments: Drug: Clarithromycin; Drug: Metronidazole; Drug: Amoxicillin hydrate; Drug: Vonoprazan

Study type: Observational

Funder types: Industry

Identifiers

NCT03219723

JapicCTI-153003 (Registry Identifier)

Vonoprazan-5002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 560 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

560 participants in 1 patient group

Vonoprazan 20 mg

Description:

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.

Treatment:

Drug: Vonoprazan

Drug: Metronidazole

Drug: Clarithromycin

Drug: Amoxicillin hydrate