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Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Positive Chronic Hepatitis B Patients

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ClinicalTrials.gov Identifier: NCT02387463
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

Brief Summary:
The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV, in clinical practice, it was expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg positive patients. However, those targets can't be get in most patients by 48 weeks of interferon treatment, and some patients need extended treatment to enhance the rate of HBeAg seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of interferon in HBeAg positive chronic hepatitis B patients will be evaluated.

Condition or disease
Chronic Hepatitis B

Detailed Description:
In this cohort study, the HBeAg positive chronic hepatitis B patients would be treated with peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during treatment and follow period. Parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The rates of HBeAg seroconversion, HBsAg loss, and sustained viral response will be evaluated after treatment and follow up.

Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Extended Peginterferon Alpha 2a(PEG-IFN a-2a) Treatment in HBeAg Positive Chronic Hepatitis B Patients
Study Start Date : March 2012
Actual Primary Completion Date : May 21, 2017
Actual Study Completion Date : May 21, 2017

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Primary Outcome Measures :
  1. rate of HBeAg seroconversion (defined as HBeAg loss with anti-HBe positive after PEG-IFN a-2a treatment and follow up) [ Time Frame: 120 weeks ]
    HBeAg seroconversion was defined as HBeAg loss with anti-HBe positive after PEG-IFN a-2a treatment and follow up.


Secondary Outcome Measures :
  1. rate of HBsAg loss (defined as HBsAg level lower than 0.05 IU/ml) [ Time Frame: 96 weeks ]
    HBsAg loss was defined as HBsAg level lower than 0.05 IU/ml.

  2. rate of sustained viral response (defined as serum HBV DNA undetectable at the end of treatment and the end of follow up) [ Time Frame: 120 weeks ]
    Sutained viral response was defined as serum HBV DNA undetectable at the end of treatment and the end of 24 weeks follow up.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the population in this cohort study was composed of HBeAg positive chronic hepatitis B patients defined as HBsAg positive, HBeAg positive, and detectable HBV DNA load with ALT level ≥41 U/L for more than 6 months.
Criteria

Inclusion Criteria:

  • HBeAg positive chronic hepatitis B patients

Exclusion Criteria:

  • Active consumption of alcohol and/or drugs
  • Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
  • History of autoimmune hepatitis
  • Psychiatric disease
  • Evidence of neoplastic diseases of the liver

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): NCT02387463


Locations
China, Beijing
Beijing Ditan hospital,Capital Medical University
Beijing, Beijing, China, 100015
Sponsors and Collaborators
Beijing Ditan Hospital

Responsible Party: Yao Xie, liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02387463     History of Changes
Other Study ID Numbers: DTXY008
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by Yao Xie, Beijing Ditan Hospital:
chronic hepatitis B
antiviral therapy
peginterferon
HBeAg seroconversion
HBsAg loss

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs