Evaluation of Antiviral Indications on Chronic HBV Infection With Different Transaminase Levels

NCT ID: NCT03740789

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-24
• Study Completion Date: 2019-06-30

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).

Conditions

Chronic Hepatitis b; ALT

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

HBeAg positive

HBeAg positive：group A(ALT≤ULN),group B(ALT 1-2ULN),group C(ALT≥2ULN) and treated subgroup (A1,B1,C1) and untreated subgroup (A2,B2,C2).

No interventions assigned to this group

HBeAg negative

HBeAg negative：group A(ALT≤ULN),group B(ALT 1-2ULN),group C(ALT≥2ULN) and treated subgroup (A1,B1,C1) and untreated subgroup (A2,B2,C2).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yan'an University Affiliated Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingli He, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

The Affiliated Hospital of Yan'an University

Yan’an, Shaanxi, China

Countries

China

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

XJTU1AF2018LSK-146

Identifier Type: -

Identifier Source: org_study_id