Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b
Keywords
Abstract
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.
Dates
| Last Verified: | 07/31/2016 |
| First Submitted: | 06/12/2016 |
| Estimated Enrollment Submitted: | 08/23/2016 |
| First Posted: | 08/29/2016 |
| Last Update Submitted: | 08/23/2016 |
| Last Update Posted: | 08/29/2016 |
| Actual Study Start Date: | 12/31/2013 |
| Estimated Primary Completion Date: | 11/30/2017 |
| Estimated Study Completion Date: | 11/30/2017 |
Condition or disease
Intervention/treatment
Drug: retreatment
Phase
Arm Groups
| 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: retreatment 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. relapse [up to 48 weeks]
Secondary Outcome Measures
1. occurence of cirrhosis and hepatocellular carcinoma [up to 48 weeks]
