Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China (GATE)

July 21, 2021 updated by: Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
China has the world's largest burden of hepatitis B virus (HBV) infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. One of the main issues in the management of patients with chronic HBV infection (CHB) is to maximize the individuals who need the treatment engaged and retained in care. However, our investigation revealed that 21.1% patients were treatment eligible but not treated based on Chinese 2019 CHB treatment guidelines, while only 213 (13.9%) patients were indicated-but-not-treated according to AASLD 2018 Hepatitis B guidance in a real-life cohort study. To maximize the individuals who need the treatment engaged and retained in care, integrated intervention strategies to address these treatment barriers are urgently needed. Therefore, we aim to propose a study to narrow the gap between in accordance with guidelines and consent to treat CHB population in EAST of China.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rui Huang, M.D., Ph.D
  • Phone Number: 20201 +86-25-83106666
  • Email: doctor_hr@126.com

Study Contact Backup

  • Name: Chao Wu, M.D., Ph.D
  • Phone Number: +86-25-83105890
  • Email: dr.wu@nju.edu.cn

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213001
        • The Third People's Hospital of Changzhou
      • Huai'an, Jiangsu, China, 223300
        • Huai'an No.4 People's Hospital
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
      • Suzhou, Jiangsu, China, 215000
        • The Affiliated Infectious Diseases Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Positive HBV surface antigen (HBsAg) for 6 months or more;
  2. Elevated ALT levels (>1×ULN) and detectable HBV DNA;
  3. Treatment-naïve;
  4. Willing to attend this study and able to provide the written informed consent.

Exclusion Criteria:

  1. Co-infection with other viral hepatitis and human immunodeficiency virus;
  2. Concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease;
  3. Patients with liver cirrhosis;
  4. Coexistence of hepatocellular carcinoma and other malignant tumor;
  5. Underwent liver transplantation before the enrollment;
  6. Severe cardiac, renal, respiratory, hematological, or psychiatric illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated intervention strategies
Other: Integrated intervention strategies
Implementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of indicated-but-not-treated CHB patients.
Time Frame: 18 months
The proportion of indicated-but-not-treated CHB patients.
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of lost to follow-up in CHB patients.
Time Frame: 18 months
18 months
The frequency of follow-up visit in CHB patients.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborators

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN-CN-320-6104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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