ClinicalTrials.gg
RecruitingNCT02883647Updated Nov 29, 2024

Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b

An observational study in Chronic Hepatitis b, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 29 studies in Hepatitis B, Chronic by Third Affiliated Hospital, Sun Yat-Sen University — 6 open to participants now, 7 under way, none of them phase 3. Hepatitis B, Chronic · Third Affiliated Hospital, Sun Yat-Sen University.

Started
2014
the only one that year
Observational
6 of 29
3 open now
Registered
9th of 29
by date

Among the 29 studies in Hepatitis B, Chronic by Third Affiliated Hospital, Sun Yat-Sen University, this one is the only one that started in 2014, is one of 6 observational ones, and was the 9th registered.

Hepatitis B, Chronic

895 studies on the registry are indexed under Hepatitis B, Chronic; 152 are open to participants now.

Browse Hepatitis B, Chronic studies →

Open to participants now

6 of the 29 studies in Hepatitis B, Chronic by Third Affiliated Hospital, Sun Yat-Sen University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 97 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 59 (61%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 29 studies in Hepatitis B, Chronic by Third Affiliated Hospital, Sun Yat-Sen University, or all of them as a file.
02

Study 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.

Read the detailed description

Patients with chronic hepatitis b were enrolled in the study. Age, sex, weight, height, symptoms (e.g., fatigue, poor appetite, jaundice), relapse, retreatment, occurrence of liver cirrhosis and hepatocellular carcinoma (HCC), mortality and survival rate were recorded in the study. We also observed the laboratory tests including the levels of white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBIL), blood urea nitrogen (BUN), creatine, hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B virus (HBV) DNA, CD4 positive T lymphocyte (CD4+T), CD8 positive T lymphocyte (CD8+T), Type 1 helper T lymphocyte (Th1), Type 2 helper T lymphocyte (Th2),fibroscan and B ultrasound. If clinical relapse occurred, patients were retreated with nucleos(t)ide analogs.

03

Conditions studied

  • Chronic Hepatitis b

Browse trials for

Keywords

  • chronic hepatitis b, nucleos(t)ide analog
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients of chronic hepatitis b

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients received anti- therapy with nucleos(t)ide analogs.
  2. Last anti-HBV therapy should continue for at least 2 years.
  3. 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.

Exclusion criteria

Exclusion Criteria:

  1. Liver cirrhosis, HCC;
  2. Patients with other factors causing active liver diseases;
  3. Pregnancy or lactation;
  4. Patients with infection or congenital immune deficiency diseases;
  5. Patients with severe diabetes, diseases, other important organ dysfunctions and other serious complications.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugEntecavir or Tenofovir

    Drug pages: Entecavir · Tenofovir

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

06

What researchers measure

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

    Time frame: up to 48 weeks

Secondary outcomes

  1. occurence of cirrhosis and hepatocellular carcinoma

    sign of cirrhosis and hepatocellular carcinoma through ultrasonography

    Time frame: up to 48 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 29862225 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Dec 2024 and a completion of Dec 2024. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 13, 2016
First posted
Aug 30, 2016
Start
Jan 1, 2014
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Nov 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02883647
Responsible party
Liang Peng (Associated Professor, Third Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Aug 30, 2016
Start date
Jan 1, 2014
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 29, 2024

Study contacts

Wenxiong Xu, Master
Contact
xwx1983@163.com
+8613760783281
Liang Peng, Doctor
Contact
pzp33@hotmail.com
+8613533978874
Liang Peng, Doctor
principal investigator · Third Affiliated Hospital, Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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