Chronic Hepatitis bNCT02883647
Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b
An observational study of Chronic Hepatitis b, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- Entecavir or Tenofovir
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients of chronic hepatitis b
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, Doctor, +8613533978874, pzp33@hotmail.com
About this study
Official title: Clinical Investigation About Therapeutic Effects and Long-term Follow-up After Ending Anti-hepatitis B Virus Therapy With Nucleos(t)Ide Analogs in Patients With Chronic Hepatitis b
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.
- Conditions
- Chronic Hepatitis b
- Being tested
- Entecavir or Tenofovir
- Keywords
- chronic hepatitis b, nucleos(t)ide analog
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir or TenofovirDrug
Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 48 weeks
Secondary outcomes (1)
occurence of cirrhosis and hepatocellular carcinoma
sign of cirrhosis and hepatocellular carcinoma through ultrasonography
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Liang Peng, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883647
- Sponsor's protocol ID
- PL
- Status last verified
- Nov 2024
- First submitted
- 13 Jun 2016
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39957751Xu 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation About Therapeutic Effects and Long-term Follow-up After Ending Anti-hepatitis B Virus Therapy With Nucleos(t)Ide Analogs in Patients With Chronic Hepatitis b
- ClinicalTrials.gov ID
- NCT02883647
- Acronym / sponsor ID
- PL
- Conditions
- Chronic Hepatitis b
- Keywords
- chronic hepatitis b, nucleos(t)ide analog
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retreatment | – | Drug: Entecavir or Tenofovir1. 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of chronic hepatitis b
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entecavir or TenofovirPatients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again | Drug | retreatment |
Primary outcome
relapse
Time frame: up to 48 weeks
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
1 secondary outcome
occurence of cirrhosis and hepatocellular carcinoma
Time frame: up to 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 39957751Wu 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.
- Derived from this study: PubMed 29862225Xu 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.
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liang Peng, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis b, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenxiong Xu, Master (+8613760783281, xwx1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse (time frame: up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883647, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.