This study is NOT currently recruiting participants.
Number
11-DK-0151
Sponsoring Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Hepatitis B; Treatment; Nucleoside/Nucleotide Analogue; Natural History
Recruitment Keyword(s)
Hepatitis B
Condition(s)
Chronic Hepatitis B e Antigen Positive; Chronic Hepatitis B e Antigen Negative
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Diabetes and Digestive and Kidney Diseases
- Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and cancer of the liver. There is no cure for the infection, but several drugs have been approved to treat it. These drugs can keep the virus levels low. They seem to be safe for short-term use. But the drugs have not yet been approved for long-term use because some of them can have serious side effects. However, stopping treatment too soon can make the infection worse and may lead to more serious forms of liver disease. Researchers have not been able to determine a when to stop treatment. They want to study people with chronic hepatitis B infection to find out the best time to stop treatment and prevent the disease from causing further liver damage.
Objectives:
- To study the safety and effectiveness of withdrawing antiviral treatment for chronic hepatitis B after at least 4 years of treatment.
- To determine whether stopping long-term antiviral treatment for chronic hepatitis B makes the infection worse.
Eligibility:
- People who are at least 18 years of age; have been taking antiviral drugs to treat chronic hepatitis B for at least 4 years; and are being evaluated to stop treatment.
Design:
- Those in the study will be screened with a physical exam, medical history, questionnaire, and blood tests. They will remain under the care of their regular doctor during the study.
- They will have an abdominal ultrasound to study scarring in the liver, if they have not had one in the past year.
- Those without detectable levels of the hepatitis B virus in their blood will stop antiviral treatment. They will have monthly blood tests for the first 6 months to check virus levels, and then every 3 months afterward.
- Those whose blood tests show an increase in virus levels will restart antiviral treatment as directed by the study doctors and their personal doctor.
- All those in the study will be monitored until the end of the study.
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INCLUSION CRITERIA: Age greater than 18 years and older, male or female HBsAg positive for greater than 6 months For HBeAg positive subjects, HBeAg loss with or without anti-HBe with a minimum period of antiviral therapy for 48 weeks after HBeAg loss was first detected. HBV DNA less than or equal to 500 IU/mL tested on at least 2 occasions over the last 6 months Antiviral therapy for a minimum of 4 years Baseline ALT or AST within the upper limit of normal. Willing and able to provide written, informed consent. Subjects must be eligible to enter protocol 07-DK-0207 or be willing to be treated by their local physician should relapse or a hepatitis flare occur. EXCLUSION CRITERIA: Presence of cirrhosis (Ishak fibrosis score 5 or 6) on any liver biopsy performed within the last 4 years. In the absence of a liver biopsy then any three of the following five variables: platelet count less than or equal to 100,000/mm(3), reversal of ALT/AST ratio, total bilirubin greater than 2.0 mg/dL, splenomegaly on ultrasound and presence of esophageal or gastric varices or portal hypertensive gastropathy on endoscopy Any history of decompensated liver disease Prior or current therapy with tenofovir or tenofovir plus emtricitabine Renal insufficiency defined as a serum creatinine greater than 1.5 mg/dL or an estimated glomerular filtration rate less than or equal to 50 mls/minute using the Cockroft and Gault formula. Anti-hepatitis C virus positivity Anti-hepatitis D virus positivity Anti-human immunodeficiency virus positivity
Age greater than 18 years and older, male or female
HBsAg positive for greater than 6 months
For HBeAg positive subjects, HBeAg loss with or without anti-HBe with a minimum period of antiviral therapy for 48 weeks after HBeAg loss was first detected.
HBV DNA less than or equal to 500 IU/mL tested on at least 2 occasions over the last 6 months
Antiviral therapy for a minimum of 4 years
Baseline ALT or AST within the upper limit of normal.
Willing and able to provide written, informed consent.
Subjects must be eligible to enter protocol 07-DK-0207 or be willing to be treated by their local physician should relapse or a hepatitis flare occur.
EXCLUSION CRITERIA:
Presence of cirrhosis (Ishak fibrosis score 5 or 6) on any liver biopsy performed within the last 4 years. In the absence of a liver biopsy then any three of the following five variables: platelet count less than or equal to 100,000/mm(3), reversal of ALT/AST ratio, total bilirubin greater than 2.0 mg/dL, splenomegaly on ultrasound and presence of esophageal or gastric varices or portal hypertensive gastropathy on endoscopy
Any history of decompensated liver disease
Prior or current therapy with tenofovir or tenofovir plus emtricitabine
Renal insufficiency defined as a serum creatinine greater than 1.5 mg/dL or an estimated glomerular filtration rate less than or equal to 50 mls/minute using the Cockroft and Gault formula.
Anti-hepatitis C virus positivity
Anti-hepatitis D virus positivity
Anti-human immunodeficiency virus positivity
Principal Investigator
Referral Contact
For more information: