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

NCT02336399 | Unknown

• 1 other identifier: DTXY002
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Hepatitis B

Keywords

HBsAg loss, interferon, HBV reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The rate of sustained HBsAg negativity and viral response in long term

  From the enrollment to 240 weeks

• The rate of sustained HBsAg negativity and viral response in subset analysis in 96 weeks

  From the enrollment to 96 weeks

• The rate of sustained HBsAg negativity and viral response in subset analysis for long term

  From the enrollment to 240 weeks

• Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in 96 weeks

  From the enrollment to 96 weeks

• Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in long term

  From the enrollment to 240 weeks

Other Outcomes (2)

• Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 96 weeks

  from the enrollment to the 96 weeks

• Exploratory outcomes on complication rates of liver cancer and decompensated cirrhosis in 240 weeks

  from the enrollment to the 240 weeks

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population in this study is composed of patients who have chronic hepatitis B and achieved HBsAg loss from interferon treatment. Eligible patients will have serum HBsAg and HBV DNA tests every 3 months for 96 weeks after finishing the interferon treatment. The sustained HBsAg response is defined as the levels of serum HBsAg mantaining below the low level of quantitation and the levels of HBV DNA remain undetectable. Following the completion of the study period, patients will be offered to participate in a long term study for further observation up to 240 weeks.

You may qualify if:

• Patients who had chronic hepatitis B and achieved HBsAg loss by interferon treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Related Publications (1)

• Pan CQ, Li MH, Yi W, Zhang L, Lu Y, Hao HX, Wan G, Cao WH, Wang XY, Ran CP, Shen G, Wu SL, Chang M, Gao YJ, Xie Y. Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens. Liver Int. 2021 Jul;41(7):1498-1508. doi: 10.1111/liv.14801. Epub 2021 Feb 16.

  PMID: 33486874 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for HBV serological and HBV DNA testing

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Yao Xie, MD

  Beijing Ditan Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Liver Diseases Center

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: September 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2021
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

CN (1)