Status:
COMPLETED
Long-Term Lamivudine Therapy for Chronic Hepatitis B
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the long-term safety and effectiveness of lamivudine therapy and the possibility of stopping therapy in patients whose hepatitis B is chronic, that is, long lasting, and which...
Detailed Description
The major aims of this study are to evaluate the long-term efficacy and safety of lamivudine therapy and the possibility of stopping therapy in a cohort of patients with chronic hepatitis B who have a...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18 years or above, male or female
- Presence of HBsAg in serum for at least 6 months.
- Previous liver biopsy histology showing chronic hepatitis with or without cirrhosis.
- Long-term (greater than 1 year) lamivudine therapy in doses of 100 mg daily.
- Normal or near normal (less than twice the upper limit of normal) serum aminotransferase levels.
- HBV DNA levels below 10(5) copies per ml while on lamivudine.
- Written informed consent.
- EXCLUSION CRITERIA:
- In women, pregnancy, breast feeding, and, in those capable of bearing children, inability to practice adequate contraception.
- Significant systemic illnesses other than liver disease, including congestive heart failure, renal failure, chronic pancreatitis, or diabetes mellitus with poor control.
- Serum creatinine greater than 1.5 mg/dL and creatinine clearance less than 50 cc/min.
- A history of clinically apparent pancreatitis or evidence of subclinical pancreatitis as shown by serum amylase values twice the upper limits of the normal range and abnormalities of the pancreas on computerized tomography or other imaging studies of the abdomen.
- Severe cirrhosis as defined by Child's stage C (Child-Pugh score of 7 or above).
- HIV infection as indicated by presence of anti-HIV in serum.
- Chronic hepatitis C as shown by the presence of anti-HCV and HCV RNA in serum.
- Immunosuppressive therapy requiring use of more than 10 mg of prednisone (or its equivalent) per day.
- Other antiviral therapy for chronic hepatitis B within the previous 3 months.
- Sensory or motor neuropathy apparent from medical history and physical examination.
Exclusion
Key Trial Info
Start Date :
July 11 2005
Trial Type :
INTERVENTIONAL
End Date :
March 31 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00120354
Start Date
July 11 2005
End Date
March 31 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892