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Trial record 84 of 518 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02883647
First received: June 13, 2016
Last updated: August 24, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Chronic Hepatitis b
Drug: Entecavir or Tenofovir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • relapse [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • occurence of cirrhosis and hepatocellular carcinoma [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
    sign of cirrhosis and hepatocellular carcinoma through ultrasonography


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Drug: Entecavir or Tenofovir
Patients in retreatment group receive nucleos(t)ide analogs therapy (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.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients of chronic hepatitis b
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02883647

Contacts
Contact: Wenxiong Xu, Master +8613760783281 xwx1983@163.com
Contact: Liang Peng, Doctor +8613533978874 pzp33@hotmail.com

Locations
China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Liang Peng, Doctor    +8613533978874    pzp33@hotmail.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
Principal Investigator: Liang Peng, Doctor Third Affiliated Hospital, Sun Yat-Sen University
  More Information

Responsible Party: Liang Peng, Associated Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02883647     History of Changes
Other Study ID Numbers: PL 
Study First Received: June 13, 2016
Last Updated: August 24, 2016
Health Authority: China: Health and Family Planning Commission of Guangdong Province

Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University:
chronic hepatitis b, nucleos(t)ide analog

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 29, 2016