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

Not Applicable

• Conditions: Chronic Hepatitis b
• Interventions: Other: Integrated intervention strategies

• Registration Number: NCT04980664
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-28
• Status Verified: 2021-07
• Study Start: 2021-07
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Integrated intervention strategies	Integrated intervention strategies	-

Primary Outcome Measures

Name	Time	Method
The proportion of indicated-but-not-treated CHB patients.	18 months	The proportion of indicated-but-not-treated CHB patients.

Secondary Outcome Measures

Name	Time	Method
The proportion of lost to follow-up in CHB patients.	18 months
The frequency of follow-up visit in CHB patients.	18 months

Trial Locations

Locations (4)

The Third People's Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China

Huai'an No.4 People's Hospital; 🇨🇳 Huai'an, Jiangsu, China

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China

The Affiliated Infectious Diseases Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China