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

Completed

• Conditions: Chronic Hepatitis B

• Registration Number: NCT02387463
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2015-03-08
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-13
• Primary Completion: 2017-05-21
• Study Completion: 2017-05-21
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of HBeAg seroconversion (defined as HBeAg loss with anti-HBe positive after PEG-IFN a-2a treatment and follow up)	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

Name	Time	Method
rate of HBsAg loss (defined as HBsAg level lower than 0.05 IU/ml)	96 weeks	HBsAg loss was defined as HBsAg level lower than 0.05 IU/ml.
rate of sustained viral response (defined as serum HBV DNA undetectable at the end of treatment and the end of follow up)	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.

Trial Locations

Locations (1)

Beijing Ditan hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China