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

NCT03740789 | Unknown DMC

• 1 other identifier: XJTU1AF2018LSK-146
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Hepatitis b; ALT

Keywords

Hepatitis B; ALT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in serum HBsAg, HBeAg ,HBeAb ,HBcAb levels between treated and untreated groups

  at baseline and 1 year

• Proportion of patients with normal alanine aminotransferase(ALT) between treated and untreated groups

  at baseline and 1 year

• Liver stiffness measurement(LSM) changes between treated and untreated groups

  at baseline and 1 year

• Proportion of patients with HBsAg loss or seroconversion

  at 1 year

• (5) Predictive values of HBV DNA,HBsAg and LSM for the antiviral indications of chronic HBV infection with different ALT levels

  at baseline

Study Arms (2)

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).

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).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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);
• Decompensated cirrhosis;
• History of hepatocellular carcinoma(HCC);
• History of liver transplantation;
• Patient with a history of antiviral treatment;
• Patient has medical condition that requires concurrent use of systemic prednisolone or other immunosuppressive agent (including chemotherapeutic agent)
• 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.)
• Patient who interrupted antiviral therapy;
• Patient with incomplete data;
• Follow up less than 1 year.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Yan'an University Affiliated Hospital: collaborator

Study Sites (1)

The Affiliated Hospital of Yan'an University

Yan’an, Shaanxi, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yingli He, M.D.,Ph.D

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: November 14, 2018
• Study Start: October 24, 2018
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 19, 2019

Record last verified: 2018-08

Locations

CN (1)