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Clinical Trials in China / NCT02883647
Recruiting Observational

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

NCT02883647 · tracked via the Priya Life Science China tracker
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Phase
Observational
Started
2014-01-01
Last updated
2024-11-29

Condition(s) studied

Chronic Hepatitis b

Investigational drug(s) / intervention(s)

Entecavir or TenofovirAll Entecavir trials (11) →All Tenofovir trials (5) →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting

More Third Affiliated Hospital, Sun Yat-Sen University trials in China

Low-dose Gemcitabine and Cisplatin and PD-1/PD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma Starting soon
Clinical Evaluation of a Novel DAB Chromogenic Tissue-Based Assay for Detecting Anti-GABABR Antibodies Starting soon
Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis Recruiting
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF Recruiting
Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF Recruiting

Other trials for the same condition

Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatitis B Patients Starting soon
A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function. Recruiting
Study of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients Starting soon
Clinical Trial of TQA3605 Tablet in Combination With Nucleos(t)Ide Analogues(NAs) Versus NAs Alone for the Treatment of Patients With Chronic Hepatitis B Virus Infection Who Have Undergone Treatment and Exhibit Low Viral Load or Poor Response Starting soon
MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02883647 on ClinicalTrials.gov ↗ ← All trials in China