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Protocol Details

Withdrawal of Therapy After Long-Term Oral Nucleos(t)ide Analogue Treatment in Patients with Chronic Hepatitis B

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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

Special Instructions

Currently Not Provided

Keywords

Hepatitis B;
Treatment;
Nucleoside/Nucleotide Analogue

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)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

- 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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Eligibility

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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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Marc G. Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 10N248D
10 CENTER DR
BETHESDA MD 20814
(301) 402-5115
mg228m@nih.gov

Marc G. Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 10N248D
10 CENTER DR
BETHESDA MD 20814
(301) 402-5115
mg228m@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01581554

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