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

NCT02348502 | Unknown

• 1 other identifier: DTXY003
• Study Type: observational
• Target: 160
• 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 -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.

Conditions

Chronic Hepatitis B

Keywords

HBsAg loss; interferon; HBV reaction; Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• the rate of HBsAg loss

  96 weeks

Eligibility Criteria

• 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 were composed of patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level after interferon treatment, and serum HBsAg and HBV DNA would be tested every 3 months for 96 weeks after finished treatment. Sustained viral response defined as serum HBV DNA maintaining undetectable during the observation period. HBsAg loss is defined as HBsAg level reached the value lower than the low limited value.

You may qualify if:

• patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level 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)

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yao Xie, MD

CONTACT

8610-84322489; xieyao00120184@sina.com

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 22, 2015
• First Posted: January 28, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

CN (1)