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

Chronic Hepatitis b Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03740789
• Other study ID #: XJTU1AF2018LSK-146
• Status: Active, not recruiting
• Start date: October 24, 2018
• Est. completion date: June 2019

Study information

• Verified date: August 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: June 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• ALT
• Chronic Hepatitis b
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
China	The Affiliated Hospital of Yan'an University	Yanan	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	The Affiliated Hospital of Yan’an University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virological response in patients with different ALT levels	Serum HBV DNA will be summarized and compared between different groups at baseline and follow-up endpoint	at 1 year
Secondary	Changes in serum HBsAg, HBeAg ,HBeAb ,HBcAb levels between treated and untreated groups		at baseline and 1 year
Secondary	Proportion of patients with normal alanine aminotransferase(ALT) between treated and untreated groups		at baseline and 1 year
Secondary	Liver stiffness measurement(LSM) changes between treated and untreated groups	LSM response is defined as LSM decrease at least a 1-kilopascal	at baseline and 1 year
Secondary	Proportion of patients with HBsAg loss or seroconversion		at 1 year
Secondary	(5) Predictive values of HBV DNA,HBsAg and LSM for the antiviral indications of chronic HBV infection with different ALT levels		at baseline