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

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04980664
• Collaborator: Gilead Sciences (Industry)
• Enrollment: 2,000
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 25
• Patients Per Site: 500
• Patients Per Site Per Month: 20

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis b	Other: Integrated intervention strategies	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China
• Anticipated Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Integrated intervention strategies	Other: Integrated intervention strategies; Implementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients.

Outcome Measures

Primary Outcome Measures

1. The proportion of indicated-but-not-treated CHB patients. [18 months]

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

Secondary Outcome Measures

1. The proportion of lost to follow-up in CHB patients. [18 months]

2. The frequency of follow-up visit in CHB patients. [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Third People's Hospital of Changzhou	Changzhou	Jiangsu	China	213001
2	Huai'an No.4 People's Hospital	Huai'an	Jiangsu	China	223300
3	Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008
4	The Affiliated Infectious Diseases Hospital of Soochow University	Suzhou	Jiangsu	China	215000

Sponsors and Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chao Wu, Principal Investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• ClinicalTrials.gov Identifier: NCT04980664
• Other Study ID Numbers: IN-CN-320-6104
• First Posted: Jul 28, 2021
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chao Wu, Principal Investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: Chronic Hepatitis b; Antiviral treatment
• Additional relevant MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic

Study Results

No Results Posted as of Jul 28, 2021