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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Hepatitis b

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Integrated intervention strategies

Group Type EXPERIMENTAL

Integrated intervention strategies

Intervention Type OTHER

Implementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients.

Interventions

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Integrated intervention strategies

Implementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No