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

Chronic Hepatitis b Clinical Trial

— GATE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04980664
• Other study ID #: IN-CN-320-6104
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2021
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Rui Huang, M.D., Ph.D
• Phone: +86-25-83106666
• Email: doctor_hr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: July 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Gilead Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of indicated-but-not-treated CHB patients.	The proportion of indicated-but-not-treated CHB patients.	18 months
Secondary	The proportion of lost to follow-up in CHB patients.		18 months
Secondary	The frequency of follow-up visit in CHB patients.		18 months