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

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ClinicalTrials.gov Identifier: NCT03740789
Recruitment Status : Active, not recruiting
First Posted : November 14, 2018
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
The Affiliated Hospital of Yan’an University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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).

Condition or disease
Chronic Hepatitis b ALT

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).

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. Virological response in patients with different ALT levels [ Time Frame: at 1 year ]
    Serum HBV DNA will be summarized and compared between different groups at baseline and follow-up endpoint


Secondary Outcome Measures :
  1. Changes in serum HBsAg, HBeAg ,HBeAb ,HBcAb levels between treated and untreated groups [ Time Frame: at baseline and 1 year ]
  2. Proportion of patients with normal alanine aminotransferase(ALT) between treated and untreated groups [ Time Frame: at baseline and 1 year ]
  3. Liver stiffness measurement(LSM) changes between treated and untreated groups [ Time Frame: at baseline and 1 year ]
    LSM response is defined as LSM decrease at least a 1-kilopascal

  4. Proportion of patients with HBsAg loss or seroconversion [ Time Frame: at 1 year ]
  5. (5) Predictive values of HBV DNA,HBsAg and LSM for the antiviral indications of chronic HBV infection with different ALT levels [ Time Frame: at baseline ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740789


Locations
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China, Shaanxi
The Affiliated Hospital of Yan'an University
Yanan, Shaanxi, China
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Hospital of Yan’an University
Investigators
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Principal Investigator: Yingli He, M.D.,Ph.D First Affiliated Hospital Xi'an Jiaotong University
  Study Documents (Full-Text)

Documents provided by First Affiliated Hospital Xi'an Jiaotong University:

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03740789     History of Changes
Other Study ID Numbers: XJTU1AF2018LSK-146
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Hepatitis B
ALT
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents