NCT04980664

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

June 28, 2021

Last Update Submit

July 21, 2021

Conditions

Chronic Hepatitis b

Keywords

Chronic Hepatitis bAntiviral treatment

Outcome Measures

Primary Outcomes (1)

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

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

    18 months

Secondary Outcomes (2)

  • The proportion of lost to follow-up in CHB patients.

    18 months

  • The frequency of follow-up visit in CHB patients.

    18 months

Study Arms (1)

Integrated intervention strategies

EXPERIMENTAL
Other: Integrated intervention strategies

Interventions

Integrated intervention strategiesOTHER

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

Integrated intervention strategies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive HBV surface antigen (HBsAg) for 6 months or more;
  • Elevated ALT levels (\>1×ULN) and detectable HBV DNA;
  • Treatment-naïve;
  • Willing to attend this study and able to provide the written informed consent.

You may not qualify if:

  • Co-infection with other viral hepatitis and human immunodeficiency virus;
  • Concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease;
  • Patients with liver cirrhosis;
  • Coexistence of hepatocellular carcinoma and other malignant tumor;
  • Underwent liver transplantation before the enrollment;
  • Severe cardiac, renal, respiratory, hematological, or psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Third People's Hospital of Changzhou

Changzhou, Jiangsu, 213001, China

Location

Huai'an No.4 People's Hospital

Huai'an, Jiangsu, 223300, China

Location

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

The Affiliated Infectious Diseases Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Rui Huang, M.D., Ph.D

CONTACT

+86-25-83106666doctor_hr@126.com

Chao Wu, M.D., Ph.D

CONTACT

+86-25-83105890dr.wu@nju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 28, 2021

Study Start

July 1, 2021

Primary Completion

December 31, 2022

Study Completion

July 31, 2023

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

CN(4)