Clinical trial NCT03740789: Evaluation of Antiviral Indications on Chronic HBV Infection With Different Transaminase Levels
Official title: Evaluation of Antiviral Indications and Therapeutic Effect by Liver Biopsy Combined With Clinical Trial Parameters on Chronic HBV Infection With Different Transaminase Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis b
ALT
Keywords: Hepatitis B
ALT
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Yan'an University Affiliated Hospital
First posted: 2018-11-14
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients underwent a liver biopsy were followed for at least 12 months(range,12-48 months) and follow-up assessments were performed at months 12, 24, 36 and 48.All the patients were detected Serum HBV DNA,HBV markers,including HBsAg,HBsAb,HBeAg,HBeAb,and HBcAb,routine biochemical tests mainly including ALT,AST,TB and ALB,Liver stiffness measurement(LSM) at baseline and endpoint.

Brief summary: It remains unknown whether antiviral therapy is beneficial for chronic hepatitis B (CHB) with normal or mild ALT.The investigators aim to evaluate the antiviral indications combining liver biopsy and clinical parameters,and further clarify the response indexes of clinical results such as virological, serological, biochemical and histological responses from a retrospective observational cohort study on antiviral therapy in HBeAg positive and negative patients with different ALT levels,especially when ALT lower 2 times upper limit of normal (ULN).

Detailed description: It is estimated that 400 million people worldwide are chronically infected with hepatitis B virus (HBV).Chronic hepatitis B (CHB) often leads to serious health conditions including decompensated liver cirrhosis and hepatocellular carcinoma (HCC). Therefore, the goal of chronic hepatitis B (CHB) therapy is to achieve sustained suppression of HBV replication and remission of liver disease.Clinical CHB management guidelines suggest recommend threshold for antiviral therapy when ALT was more than 2 times ULN.No antiviral drugs are recommended for patients with normal ALT or mildly elevated ALT unless they exhibit symptoms of advanced fibrosis or liver cirrhosis.But chronic HBV infections with normal or mild ALT levels may develop latently into CHB,even cirrhosis and hepatocellular carcinoma (HCC).The ALT level is easily influenced by many factors.Antiviral therapy may still be needed for some HBV patients with normal or mildly abnormal ALT levels. Therefore, the investigator's purpose is to evaluate of antiviral indications and therapeutic effect by liver biopsy and clinical trial parameters on chronic HBV infection with different ALT levels,especially when ALT lower 2 times upper limit of normal (ULN).

Eligibility criteria: Inclusion Criteria:All of below

1. Patients with chronic HBV infection,defined as those in whom presence of serum hepatitis B surface(HBsAg) for more than 6 months;
2. All patients had underwent a liver biopsy;
3. All patients signed the informed consent before liver biopsy;
4. No history use of interferon or Nucleoside analogue treatment.

Exclusion Criteria:Any of below

1. Co-infection with hepatitis A virus(HAV),hepatitis C virus(HCV),hepatitis D virus(HDV) hepatitis E virus(HEV) and/or human immunodeficiency virus(HIV);
2. Decompensated cirrhosis;
3. History of hepatocellular carcinoma(HCC);
4. History of liver transplantation;
5. Patient with a history of antiviral treatment;
6. Patient has medical condition that requires concurrent use of systemic prednisolone or other immunosuppressive agent (including chemotherapeutic agent)
7. Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis,alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.)
8. Patient who interrupted antiviral therapy;
9. Patient with incomplete data;
10. Follow up less than 1 year.

Primary outcomes:
measure: Virological response in patients with different ALT levels
timeFrame: at 1 year
Secondary outcomes:
measure: Changes in serum HBsAg, HBeAg ,HBeAb ,HBcAb levels between treated and untreated groups
timeFrame: at baseline and 1 year
measure: Proportion of patients with normal alanine aminotransferase(ALT) between treated and untreated groups
timeFrame: at baseline and 1 year
measure: Liver stiffness measurement(LSM) changes between treated and untreated groups
timeFrame: at baseline and 1 year
measure: Proportion of patients with HBsAg loss or seroconversion
timeFrame: at 1 year
measure: (5) Predictive values of HBV DNA,HBsAg and LSM for the antiviral indications of chronic HBV infection with different ALT levels
timeFrame: at baseline
Other outcomes:
Locations:
city: Yanan
country: China
facility: The Affiliated Hospital of Yan'an University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yingli He, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: