Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment

Chronic Hepatitis B Clinical Trial

Official title:

Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02336399
• Other study ID #: DTXY002
• Status: Active, not recruiting
• Phase: N/A
• First received: January 8, 2015
• Last updated: November 13, 2017
• Start date: September 2008
• Est. completion date: December 2021

Study information

• Verified date: November 2017
• Source: Beijing Ditan Hospital
• Contact: n/a
• Is FDA regulated: No
• 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 HBeAg-negative patients, as well as the ultimate treatment goal in CHB. However, some patients who have achieved HBsAg loss would reverse back to HBsAg positive, or even become HBV reactive with recurrence of viremia. In current study, the viral and HBsAg response in patients who have achieved HBsAg loss by interferon (IFN) treatment will be observed for 96 weeks after the completion of IFN treatment. The primary analysis will be performed at the end of 96 weeks. Following the completion of the study period of 96 weeks, patients will be offered to participate in a long term study for further observation of additional 144 weeks (total of 240 weeks from the enrollment).

Description:

Chronic hepatitis B patients who have achieved HBsAg loss from 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. Their liver function and chemistry tests are also performed every 3 months. The liver ultrasonic examination would be taken every 3-6 months. The primary measurement is the percentage of patients who have positive HBsAg and/or a detectable level of HBV DNA. Following the completion of the study period, patients will be offered to participate in a long term study for further observation of additional 144 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who had chronic hepatitis B and achieved HBsAg loss 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Beijing Ditan Hospital,Capital Medical University	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
Other	Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 96 weeks	Percentage of patient who have clinical cirrhosis or liver cancer during the observational period	from the enrollment to the 96 weeks
Other	Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 240 weeks	Percentage of patient who have clinical cirrhosis or liver cancer during the observational period	from the enrollment to the 240 weeks
Primary	The rate of sustained HBsAg negativity and viral response in 96 weeks	The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 96 weeks after completing treatment with interferon	From the enrollment to 96 weeks
Secondary	The rate of sustained HBsAg negativity and viral response in long term	The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 240 weeks after completing treatment with interferon	From the enrollment to 240 weeks
Secondary	The rate of sustained HBsAg negativity and viral response in subset analysis in 96 weeks	The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 96 weeks after completing treatment with interferon mono-therapy versus those who have the same endpoints after the completion of the interferon therapy in the combination or sequencing of oral antiviral therapy	From the enrollment to 96 weeks
Secondary	The rate of sustained HBsAg negativity and viral response in subset analysis for long term	The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 240 weeks after completing treatment with interferon mono-therapy versus those who have the same endpoints after completing the interferon therapy in the combination or sequencing of oral antiviral therapy	From the enrollment to 240 weeks
Secondary	Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in 96 weeks	Clinical features and baseline factors will be analyzed by comparing patients who have sustained HBsAg negativity and viral response vs. those who have no sustained endpoints at week 96.	From the enrollment to 96 weeks
Secondary	Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in long term	Clinical features and baseline factors will be analyzed by comparing patients who have sustained HBsAg negativity and viral response vs. those who have no sustained endpoints at week 240.	From the enrollment to 240 weeks