Skip to main content
OpenTrials
Completed

NCT Number: NCT02387463

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beijing Ditan Hospital

Other

Registry information

Official study title

Efficacy of Extended Peginterferon Alpha 2a(PEG-IFN a-2a) Treatment in HBeAg Positive Chronic Hepatitis B Patients

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2015
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.