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

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02883647

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis b	Drug: Entecavir or Tenofovir

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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
retreatment Patients with HBV DNA > 2000 IU/ml and ALT ≥ 5×ULN; 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 Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again
non-retreatment Patients with HBV DNA ≤ 2000 IU/ml; Patients with HBV DNA > 2000 IU/ml and ALT ≤ 2×ULN; Patients with HBV DNA > 2000 IU/ml and 2×ULN < ALT ≤ 5×ULN, but have no clinical symptoms.

Arm

Intervention/Treatment

retreatment

Patients with HBV DNA > 2000 IU/ml and ALT ≥ 5×ULN; 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

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

non-retreatment

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

Outcome Measures

Primary Outcome Measures

relapse [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

Secondary Outcome Measures

occurence of cirrhosis and hepatocellular carcinoma [up to 48 weeks]
sign of cirrhosis and hepatocellular carcinoma through ultrasonography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.