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

Sun Yat-sen University

Status: Enrolling

Conditions: Chronic Hepatitis b

Treatments: Drug: Entecavir or Tenofovir

Study type: Observational

Funder types: Other

Identifiers

NCT02883647

PL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

retreatment

Description:

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.

Treatment:

Drug: Entecavir or Tenofovir

non-retreatment

Description:

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.