Sustained Viral Response in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion After Interferon Therapy

Chronic Hepatitis B Clinical Trial

Official title:

Sustained Viral Response and Clincal Relapse in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion by Interferon Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02412592
• Other study ID #: DTXY009
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2015
• Last updated: August 17, 2016
• Start date: January 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Beijing Ditan Hospital
• Contact: yao xie, MD
• Phone: 8610-84322210
• Email: xieyao00120184[@]sina.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational

Clinical Trial Summary

Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients. However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur in some patients who achieved HBeAg seronconversion by interferon treatment. In this study, the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg seronconversion after interferon treatment and the factors associated with viral and clinical relapse will be observed.

Description:

HBeAg positive chronic hepatitis B patients achieved HBeAg seronconversion by interferon treatment will be enrolled and observed for 156 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is sustained viral response, and secondary endpoints is HBV DNA reaction and clinical relapse defined as virla relapse with abnormal ALT during observation period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients who achieved HBeAg seroconversion by interferon treatment.

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
China	Yao Xie	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sustained viral response	The serum HBV DNA load and HBeAg level will be tested every 3 month for 156 weeks after completed treatment in patients who achieved HBeAg seroconversion by interferon treatment. The rate of sustained viral response defined HBV DNA maintaining undetectable during observation period will be evaluated.	156 weeks	Yes
Secondary	HBV DNA reaction	HBV DNA reaction was defined as HBV DNA load reverse back to detectable during observation period.	156 weeks	Yes
Secondary	clinical relapse	clinical relapse is defined as virla relapse with abnormal ALT during observation period	156 weeks	Yes