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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

Tracking Information
First Submitted Date October 28, 2018
First Posted Date November 14, 2018
Last Update Posted Date February 19, 2019
Actual Study Start Date October 24, 2018
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03740789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 12, 2018)
  • Changes in serum HBsAg, HBeAg ,HBeAb ,HBcAb levels between treated and untreated groups [ Time Frame: at baseline and 1 year ]
  • Proportion of patients with normal alanine aminotransferase(ALT) between treated and untreated groups [ Time Frame: at baseline and 1 year ]
  • 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
  • Proportion of patients with HBsAg loss or seroconversion [ Time Frame: at 1 year ]
  • (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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Chronic Hepatitis b
  • ALT
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 12, 2018)
700
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03740789
Other Study ID Numbers XJTU1AF2018LSK-146
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement Not Provided
Responsible Party First Affiliated Hospital Xi'an Jiaotong University
Study Sponsor First Affiliated Hospital Xi'an Jiaotong University
Collaborators The Affiliated Hospital of Yan’an University
Investigators
Principal Investigator: Yingli He, M.D.,Ph.D First Affiliated Hospital Xi'an Jiaotong University
PRS Account First Affiliated Hospital Xi'an Jiaotong University
Verification Date August 2018