Clinical trial NCT02883647: Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis b
Keywords: chronic hepatitis b, nucleos(t)ide analog
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of chronic hepatitis b

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients received anti-HBV 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:

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

Primary outcomes:
measure: relapse
timeFrame: up to 48 weeks
Secondary outcomes:
measure: occurence of cirrhosis and hepatocellular carcinoma
timeFrame: up to 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.