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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
The Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Wenxiong Xu, Master
xwx1983@163.com
+8613760783281
Backup
Liang Peng, Doctor
pzp33@hotmail.com
+8613533978874
Time Frame
Start Date: 2014-01-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 100
Treatments
retreatment
1. Patients with HBV DNA \> 2000 IU/ml and ALT ≥ 5×ULN;~2. 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.
non-retreatment
1. Patients with HBV DNA ≤ 2000 IU/ml;~2. Patients with HBV DNA \> 2000 IU/ml and ALT ≤ 2×ULN;~3. Patients with HBV DNA \> 2000 IU/ml and 2×ULN \< ALT ≤ 5×ULN, but have no clinical symptoms.
Related Therapeutic Areas
Sponsors
Leads: Third Affiliated Hospital, Sun Yat-Sen University