Clinical trial NCT04980664: Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China
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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis b
Keywords: Chronic Hepatitis b
Antiviral treatment
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2021-07-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of indicated-but-not-treated CHB patients.
timeFrame: 18 months
Secondary outcomes:
measure: The proportion of lost to follow-up in CHB patients.
timeFrame: 18 months
measure: The frequency of follow-up visit in CHB patients.
timeFrame: 18 months
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The Third People's Hospital of Changzhou
state: Jiangsu
city: Huai'an
country: China
facility: Huai'an No.4 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Suzhou
country: China
facility: The Affiliated Infectious Diseases Hospital of Soochow University
state: Jiangsu
Study officials:
References: