NCT06550622

Brief Summary

The goal of this observational study is to learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay. The main question it aims to answer is: What's the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay? HBsAg NEXT assay technology (lower limit of detection for HBsAg is 0.005 IU/ml) and current ARCHITECT HBsAg assay (lower limit of detection for HBsAg is 0.05 IU/ml) are applied for HBsAg detection in patients achieving functional cure, and to compare the difference in HBsAg reversion rate 48 weeks off treatment under the two types of criteria.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress58%
Aug 2024Aug 2027

First Submitted

Initial submission to the registry

August 8, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

August 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2027

Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

August 8, 2024

Last Update Submit

August 8, 2024

Conditions

Hepatitis B, Chronic

Keywords

HBsAg next assayFunctional cureHBsAg lossHBsAg reversion

Outcome Measures

Primary Outcomes (1)

  • HBsAg reversion rate

    HBsAg reversion rate in patients with HBsAg loss by Abbott's HBsAg next assay at week 48 off treatment

    48 weeks

Secondary Outcomes (4)

  • Proportion of patients who were HBsAg positive

    48 weeks

  • HBsAg seroconversion rate

    48 weeks

  • Surface antibody disappearing rates

    48 weeks

  • Viral reactivation rate

    48 weeks

Study Arms (2)

Group A

CHB patients with HBsAg level\<0.005 IU/mL

Group B

CHB patients with 0.005 IU/mL\< HBsAg level \< 0.05 IU/mL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subject studied were HBsAg-negative, HBeAg-negative, and anti-HBe positive patients with chronic hepatitis B

You may qualify if:

  • HBsAg-negative by Abbott's HBsAg Test and HBeAg-negative;
  • Having serum specimens retained at baseline and at 48 weeks off treatment follow up;
  • Being willing to follow up regularly for 1 year.

You may not qualify if:

  • Patients with hepatitis B cirrhosis in the compensated and decompensated stages: this includes patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 prior to NUC treatment, or who have had complications of the decompensated stage of cirrhosis, such as ascites, hepatic encephalopathy, or ruptured oesophago-gastric fundal varices bleeding;
  • Combined HAV, HCV, HDV, HEV, HIV infections, alcoholic liver disease, inherited metabolic liver disease, pharmacological liver disease, non-alcoholic fatty liver disease, autoimmune liver disease and other chronic liver diseases;
  • Primary hepatocellular carcinoma or those with AFP greater than 100 ng/ml at screening and imaging suggestive of possible malignant hepatic occupancy; or patients with AFP greater than 100 ng/ml for a sustained period of 3 months;
  • Patients with a combination of other malignant tumours (excluding those who have been cured);
  • Patients with severe diseases or uncontrolled disease
  • Those who are also participating in other clinical studies;
  • Patients deemed unsuitable by the investigator to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fahong Li

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

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

Fahong Li

CONTACT

13524212580minelihong@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 13, 2024

Study Start

August 10, 2024

Primary Completion (Estimated)

August 10, 2027

Study Completion (Estimated)

August 10, 2027

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations

CN(1)