A Study on Vonoprazan in the Real-world Clinical Practice in China

A Multi-center, Single-arm, Prospective, Non-interventional Study on Vonoprazan in the Real-world Clinical Practice in China

The purpose of this study is to evaluate the safety of Vonoprazan by assessing all adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) in routine clinical settings in China.

This is a prospective, non-interventional study in Chinese participants with RE who are receiving or will receive the standard treatment of vonoprazan. This study will assess the safety and effectiveness of vonoprazan in the real-world clinical practice.

The study will enroll approximately 3000 participants. The data will be collected through participants' medical records, self-reported questionnaires, and recorded information on symptom via diaries. All the participants will be assigned to a single observational cohort:

• Participants with RE

The multi-center trial will be conducted in China. The standard treatment will be of 4 weeks or it may reach up to 8 weeks if the dosing proves insufficient. All participants will be followed up for additional 2 weeks after the standard treatment. The overall duration of the study will be approximately 10 weeks.

Inclusion Criteria:

1. Must be undergoing treatment with Vonoprazan.
2. Must be at least 18 years old.
3. Provide signed informed consent indicating that they (or a legally acceptable representative) have been informed of all pertinent aspects of the study and are willing to participate.

Exclusion Criteria:

1. Are currently enrolled in or plan to participate in any other clinical trials (that is interventional study).
2. Are contraindicated for Vonoprazan according to Product Package Insert.
3. With a known hepatic function impairment, including jaundice.