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

Takeda

Status: Completed

Conditions: Esophagitis Peptic

Study type: Observational

Funder types: Industry

Identifiers

NCT04501627

Vonoprazan-4007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

Participants with RE

Description:

Participants diagnosed with RE who have received 20 milligram (mg) of vonoprazan in routine clinical practice, will be observed prospectively. Data will be collected from participants' medical records, self-reported questionnaires and recorded information on symptom via diaries.