The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Location status: Recruiting
NCT Number: NCT02883647
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Guangzhou, Guangdong, 510630, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again
Time frame: 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
Time frame: up to 48 weeks
sign of cirrhosis and hepatocellular carcinoma through ultrasonography
Contact information is provided by the study sponsor or research team.
Liang Peng, Doctor
CONTACT
Wenxiong Xu, Master
CONTACT
Third Affiliated Hospital, Sun Yat-Sen University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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