Sustained Viral Response in Patients Achieved HBsAg Level≤100 IU/ml After Completed Interferon Treatment

Chronic Hepatitis B Clinical Trial

Official title:

Sustained Viral Response and HBsAg Level Changes in Chronic Hepatitis B Patients Who Achieved HBsAg Level≤100 IU/ml After Completed Interferon Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02348502
• Other study ID #: DTXY003
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2015
• Last updated: August 17, 2016
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Beijing Ditan Hospital
• Contact: Yao Xie, MD
• Phone: 8610-84322489
• 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). HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring good long term outcomes in patients with chronic hepatitis B. it was not clear whether patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained viral response and the state of HBsAg level≤100 IU/ml.

Description:

The patients with chronic hepatitis B and achieved HBsAg level≤100 IU/ml after completed interferon treatment will be enrolled and observed for 96 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 HBV DNA reaction. The secondary endpoints is HBsAg loss.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients who had chronic hepatitis B and achieved HBsAg level=100 IU/ml with undetectable HBV DNA level 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	liver disease center, Beijing Ditan Hospital	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	the rate of sustained viral response	The serum HBV DNA will be tested every 3 month for 96 weeks after completed treatment in chronic hepatitis B patients who achieved serum HBsAg level=100 IU/ml with HBV DNA undetectable by interferon therapy. The rate of sustained viral response defined HBV DNA level maintaining undetectable during observation period will be evaluated, and HBV reaction is defined as serum HBV DNA reverse back to detectable level.	96 weeks	No
Secondary	the rate of HBsAg loss	The serum HBsAg level will be tested every 3 month after completed treatment. The rate of HBsAg loss defined as HBsAg level reached the value lower than the low limited value will be evaluated after 96 weeks follow-up.	96 weeks	No