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

Primary Purpose

Chronic Hepatitis b

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Integrated intervention strategies
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Hepatitis b focused on measuring Chronic Hepatitis b, Antiviral treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Third People's Hospital of Changzhou
  • Huai'an No.4 People's Hospital
  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
  • The Affiliated Infectious Diseases Hospital of Soochow University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Integrated intervention strategies

Arm Description

Outcomes

Primary Outcome Measures

The proportion of indicated-but-not-treated CHB patients.
The proportion of indicated-but-not-treated CHB patients.

Secondary Outcome Measures

The proportion of lost to follow-up in CHB patients.
The frequency of follow-up visit in CHB patients.

Full Information

First Posted
June 28, 2021
Last Updated
July 21, 2021
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04980664
Brief Title
Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China
Acronym
GATE
Official Title
Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
Keywords
Chronic Hepatitis b, Antiviral treatment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated intervention strategies
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Integrated intervention strategies
Intervention Description
Implementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients.
Primary Outcome Measure Information:
Title
The proportion of indicated-but-not-treated CHB patients.
Description
The proportion of indicated-but-not-treated CHB patients.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The proportion of lost to follow-up in CHB patients.
Time Frame
18 months
Title
The frequency of follow-up visit in CHB patients.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive HBV surface antigen (HBsAg) for 6 months or more; Elevated ALT levels (>1×ULN) and detectable HBV DNA; Treatment-naïve; Willing to attend this study and able to provide the written informed consent. Exclusion Criteria: Co-infection with other viral hepatitis and human immunodeficiency virus; Concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease; Patients with liver cirrhosis; Coexistence of hepatocellular carcinoma and other malignant tumor; Underwent liver transplantation before the enrollment; Severe cardiac, renal, respiratory, hematological, or psychiatric illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Huang, M.D., Ph.D
Phone
+86-25-83106666
Ext
20201
Email
doctor_hr@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Wu, M.D., Ph.D
Phone
+86-25-83105890
Email
dr.wu@nju.edu.cn
Facility Information:
Facility Name
The Third People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213001
Country
China
Facility Name
Huai'an No.4 People's Hospital
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
The Affiliated Infectious Diseases Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China

12. IPD Sharing Statement

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

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