NCT02738554

Brief Summary

Treatment cessation in chronic hepatitis B is associated with high rates of disease relapse. However patients who achieve the seroclearance of hepatitis B surface antigen (HBsAg) (\<0.05 IU/mL) show good off-treatment durability after treatment cessation. Through the quantification of HBsAg, the study aims to investigate how low should quantitative HBsAg be before once can achieve successful disease control after treatment cessation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

April 8, 2016

Last Update Submit

February 6, 2020

Conditions

Chronic Hepatitis B

Keywords

HBVtreatment cessationHBsAgHBcrAgnucleoside analogueentecavirtenofovir

Outcome Measures

Primary Outcomes (1)

  • Off-treatment durability

    HBV DNA \<2,000 IU/mL

    up to 48 weeks

Secondary Outcomes (3)

  • HBV DNA <200 IU/mL

    up to 48 weeks

  • HBV DNA <20 IU/mL

    up to 48 weeks

  • HBsAg seroclearance (<0.05 IU/mL)

    up to 48 weeks

Study Arms (1)

Treatment cessation arm

OTHER

Cessation of treatment as according to European Association for the Study of the Liver Guidelines for chronic hepatitis B

Other: Treatment cessation

Interventions

Treatment cessationOTHER

Cessation of nucleoside analogue therapy following European Association for the Study of the Liver guidelines

Treatment cessation arm

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years.
  • HBsAg-positive patients on entecavir or tenofovir therapy
  • Fulfill the European Association for the Study of the Liver of NA cessation:
  • HBeAg-positive at NA commencement: stable HBeAg seroconversion and undetectable HBV DNA and completed 12 months of consolidation therapy
  • HBeAg-negative: Virological suppression with undetectable HBV DNA (\<10 IU/mL) for more than 3 years.
  • Normal levels of serum alanine aminotransferase (ALT) documented on two separate occasions 6 months apart.
  • Serum HBsAg between \<200 IU/mL prior to NA cessation.

You may not qualify if:

  • Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
  • Significant alcohol intake (\>30 grams per day).
  • Prior history of hepatocellular carcinoma (HCC) or any radiologic suspicion of HCC.
  • Decompensated liver disease (defined as Child's B or C cirrhosis), or presence of cirrhotic complications, including variceal disease, ascites, or history of hepatic encephalopathy.
  • Patient previously or currently on interferon therapy.
  • History of immunosuppressive therapy or organ transplantation.
  • Serious medical illness or malignancy.
  • Patient previously or currently prescribed interferon therapy.
  • Confirmed or radiologic suspicion of HCC.
  • Serious medical illness or malignancy. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Seto WK, Liu KS, Mak LY, Cloherty G, Wong DK, Gersch J, Lam YF, Cheung KS, Chow N, Ko KL, To WP, Fung J, Yuen MF. Role of serum HBV RNA and hepatitis B surface antigen levels in identifying Asian patients with chronic hepatitis B suitable for entecavir cessation. Gut. 2021 Apr;70(4):775-783. doi: 10.1136/gutjnl-2020-321116. Epub 2020 Aug 5.

    PMID: 32759300DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Withholding Treatment

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Wai-Kay Seto, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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
Clinical Assistant Professor

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 14, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)