Hepatitis b drug holiday: study tests if stopping pills is safe
NCT ID NCT01581554
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 7 times
Summary
This study tested whether people with chronic hepatitis B who had been on antiviral drugs for at least 4 years could safely stop treatment. Fifteen adults were monitored with monthly blood tests for 6 months after stopping, then every 3 months. The goal was to see if the virus stayed at low levels without causing liver damage or dangerous flare-ups.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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15 people
The number who actually took part.
- Started
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May 2011
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Liver clinic population and community
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States