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

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.

Study Overview

• Status: Completed
• Conditions: Esophagitis Peptic

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 000000
      • Beijing Hospital
    • Beijing, Beijing, China, 102218
      • Beijing Tsinghua Changgung Hospital
  • Chongqing
    • Yongchuan, Chongqing, China, 402160
      • Yongchuan Hospital of Chongqing Medical University
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital, Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510260
      • the Second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
    • Shenzhen, Guangdong, China, 518052
      • Huazhong University of Science and Technology Union Shenzhen Hospital
    • Zhuhai, Guangdong, China, 519050
      • Zhuhai People's Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150036
      • Heilongjiang Provincial Hospital (Nanshang)
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial Peoples Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
  • Jiangsu
    • Changshu, Jiangsu, China, 215500
      • Changshu No.2 People's Hospital
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210000
      • The Affiliated Drum Tower Hospital of Nanjing University
    • Nanjing, Jiangsu, China, 210029
      • Nanjing First Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330006
      • JiangXi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
    • Qingdao, Shandong, China, 266035
      • Qilu Hospital of Shandong University (Qingdao)
    • Weifang, Shandong, China, 261041
      • Weifang Peoples Hospital
    • Yantai, Shandong, China, 264100
      • Yantai Affiliated Hospital of Binzhou Medical College
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610031
      • Chengdu Third People's Hospital
  • Tianjin
    • Tianjing, Tianjin, China, 300052
      • General Hospital of Tianjin
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated hospital of Zhejiang University school of medicine
    • Hangzhou, Zhejiang, China, 310000
      • The Affiliated Hospital of Hangzhou Normal University
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial people's hospital
    • Ningbo, Zhejiang, China, 315105
      • The Affiliated Hospital of Medical School of Ningbo University
    • Wenzhou, Zhejiang, China, 325000
      • Wenzhou Central Hospital
    • Wenzhou, Zhejiang, China, 325027
      • The Second Affiliated Hospital of Wenzhou Medical College
    • Yiwu, Zhejiang, China, 32200
      • The Fourth Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese participants who are prescribed with vonoprazan treatment in real-world clinical practice will be observed prospectively.

Description

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.

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
Participants with RE; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting one or More AEs		Up to Week 10
Percentage of Participants Reporting one or More SAEs		Up to Week 10
Percentage of Participants Reporting one or More ADRs	ADRs refers to AE related to administered drug.	Up to Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Endoscopic Healing of Reflux Esophagitis (RE) During 4-week Treatment	Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break less than [<] 5 millimeter [mm]), Grade B (Mucosal break greater than or equal to [>=] 5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the esophageal circumference) and Grade D (Mucosal break >=75 percent [%] of the esophageal circumference).	Baseline up to Week 4
Percentage of Participants with Endoscopic Healing of RE During 8-week Treatment	Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break >=5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the esophageal circumference) and Grade D (Mucosal break >=75% of the esophageal circumference).	Baseline up to Week 8
Percentage of RE Participants Without Gastroesophageal Reflux Disease (GERD) Typical Symptoms	The severity of participants' GERD symptoms based on the investigator's assessment among all participants will be evaluated at Baseline and Week 4. GERD symptoms will be assessed on a 5-point scale, wherein 1= no symptom, 2= mild, 3= moderate, 4= severe and 5= very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP). The participants without any GERD typical symptoms will be analyzed.	Baseline and Week 4
Percentage of Participants With Heartburn at Baseline Achieving Complete Heartburn Symptom Relief During the First Week of Treatment	The complete relief of heartburn symptom is defined as no such symptom occurred on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete heartburn symptom relief) divided by (the total number of participants) *100%.	Baseline up to Week 1
Percentage of Participants with Night Time Heartburn at Baseline Achieving Complete Night Time Heartburn Symptom Relief During the First Week of Treatment	The complete relief of night time heartburn symptoms is defined as no such symptom occurred on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time heartburn symptom relief) divided by (the total number of participants) *100%.	Baseline up to Week 1
Percentage of Participants With Acid Regurgitation at Baseline Achieving Complete Acid Regurgitation Symptom Relief During the First Week of Treatment	The complete relief of acid regurgitation symptom is defined as no symptoms of acid regurgitation occurring on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete acid regurgitation symptom relief) divided by (the total number of participants) *100%.	Baseline up to Week 1
Percentage of Participants With Night Time Acid Regurgitation Symptom at Baseline Achieving Complete Night Time Acid Regurgitation Symptom Relief During the First Week of Treatment	The complete relief of acid regurgitation symptoms durng night time is defined as no symptoms of acid regurgitation occurring on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time acid regurgitation symptom relief) divided by (the total number of participants) *100%.	Baseline up to Week 1
Change from Baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score at Week 4	GerdQ is a self-completed participant questionnaire that is used to assess whether the following symptoms of RE are improved under treatment: heartburn, regurgitation, stomach pain, nausea, sleep disturbance and use of additional medication due to heartburn/regurgitation. Symptom frequency will be assessed for the week passed using following answers: 0 days, 1 day, 2-3 days, and 4-7 days. Each answer will be assigned a score from 0 to 3 (heartburn, regurgitation, sleep disturbance and use of additional medication due to heartburn/regurgitation) or from 3 to 0 (stomach pain, nausea). Total score will be calculated as a sum of 6 individual scores. GerdQ score was calculated as sum of these scores, giving a total score ranging from 0 to 18. When GerdQ >=8, the participants could be symptom based diagnosed as GERD. Total score of 0 to 2 points= 0% likelihood of GERD; 3 to 7 points= 50% likelihood of GERD; 8 to 10 points= 79% likelihood of GERD; 11 to 18 points= 89% likelihood of GERD.	Baseline up to Week 4

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Medical Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information about this study, click this link.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2020
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Esophagitis
• Other Study ID Numbers: Vonoprazan-4007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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