Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b
Recruiting · NCT02883647 · Observational (researchers observe without assigning treatment) · Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
View the official record on ClinicalTrials.gov →Interventions studied
Entecavir or Tenofovir
What this trial is 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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- The Third Affiliated Hospital of Sun Yat-sen University - Guangzhou, Guangdong, China