NCT02883647

Brief Summary

The study is to observe the therapeutic effects and long-term follow-up after ending anti-HBV therapy with nucleos(t)ide analogs in patients with chronic hepatitis b.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 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 Start

First participant enrolled

January 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

11 years

First QC Date

June 13, 2016

Last Update Submit

November 26, 2024

Conditions

Chronic Hepatitis b

Keywords

chronic hepatitis b, nucleos(t)ide analog

Outcome Measures

Primary Outcomes (1)

  • relapse

    non-relapse:serum HBV DNA \< 2000 IU/ml; virologic relapse: serum HBV DNA \> 2000 IU/ml; clinical relapse:serum HBV DNA \> 2000 IU/ml and ALT \> 2×ULN

    up to 48 weeks

Secondary Outcomes (1)

  • occurence of cirrhosis and hepatocellular carcinoma

    up to 48 weeks

Study Arms (2)

retreatment

1. Patients with HBV DNA \> 2000 IU/ml and ALT ≥ 5×ULN; 2. Patients with HBV DNA \> 2000 IU/ml and 2×ULN \< ALT ≤ 5×ULN, but have clinical symptoms. Intervention: Patients of this group will receive Entecavir 0.5mg/d or Tenofovir 300mg/d again.

Drug: Entecavir or Tenofovir

non-retreatment

1. Patients with HBV DNA ≤ 2000 IU/ml; 2. Patients with HBV DNA \> 2000 IU/ml and ALT ≤ 2×ULN; 3. Patients with HBV DNA \> 2000 IU/ml and 2×ULN \< ALT ≤ 5×ULN, but have no clinical symptoms.

Interventions

Entecavir or TenofovirDRUG

Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again

retreatment

Eligibility Criteria

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

patients of chronic hepatitis b

You may qualify if:

  • Patients received anti-HBV therapy with nucleos(t)ide analogs.
  • Last anti-HBV therapy should continue for at least 2 years.
  • For HBeAg positive patients, HBV DNA should keep negative for at least 1 year after HBeAg seroconversion before the therapy ending; for HBeAg negative patients, HBV DNA should keep negative for at least 2 years before the therapy ending.

You may not qualify if:

  • Liver cirrhosis, HCC;
  • Patients with other factors causing active liver diseases;
  • Pregnancy or lactation;
  • Patients with HIV infection or congenital immune deficiency diseases;
  • Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (2)

  • Wu L, Lai J, Luo Q, Zhang Y, Lin C, Xie D, Chen Y, Deng H, Gao Z, Peng L, Xu W. Long-term hepatitis B surface antigen kinetics after nucleos(t)ide analog discontinuation in patients with noncirrhotic chronic hepatitis B. Liver Res. 2024 Jul 6;8(3):179-187. doi: 10.1016/j.livres.2024.07.001. eCollection 2024 Sep.

    PMID: 39957751DERIVED

  • Xu WX, Zhang Q, Zhu X, Lin CS, Chen YM, Deng H, Mei YY, Zhao ZX, Xie DY, Gao ZL, Xie C, Peng L. 48-Week Outcome after Cessation of Nucleos(t)ide Analogue Treatment in Chronic Hepatitis B Patient and the Associated Factors with Relapse. Can J Gastroenterol Hepatol. 2018 May 10;2018:1817680. doi: 10.1155/2018/1817680. eCollection 2018.

    PMID: 29862225DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavirTenofovir

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)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Liang Peng, Doctor

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxiong Xu, Master

CONTACT

+8613760783281xwx1983@163.com

Liang Peng, Doctor

CONTACT

+8613533978874pzp33@hotmail.com

Study Design

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

Study Record Dates

First Submitted

June 13, 2016

First Posted

August 30, 2016

Study Start

January 1, 2014

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

CN(1)