Lamivudine for Chronic Hepatitis B
To assess the safety, antiviral activity and clinical benefit of lamivudine (3-thiacytidine:
3TC) in chronic hepatitis B, we will treat 60 patients with oral lamivudine in a dose of 100
mg daily for up to five years. Lamivudine is a nucleoside analogue which is used
extensively in patients with HIV infection and is being studied in controlled trials in
chronic hepatitis B. In this study, we will evaluate lamivudine in patients with four
different forms of chronic hepatitis B: (A) Atypical serology (HBeAg negative), (B)
extra-hepatic manifestations, (C) chronic delta hepatitis, (D) typical HBeAg- positive
chronic hepatitis B. After evaluation and liver biopsy, patients will receive lamivudine,
100 mg orally once daily for 1 year, being monitored at regular intervals for symptoms of
liver disease, side effects of lamivudine, serum biochemical and hematologic indices, and
serologic markers of hepatitis B (and D) virus replication. At one year, patients will have
a repeat medical evaluation and liver biopsy. If there is virologic, biochemical or
histologic evidence of benefit, therapy will be continued thereafter for up to 5 years.
Patients who develop viral resistance to lamivudine may be offered therapy with higher doses
of lamivudine (300 mg per day). The activity of lamivudine will be assessed by changes in
levels of HBV DNA or HDV RNA during treatment and its efficacy by loss of viral markers and
improvements in aminotransferases and liver histology.
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
950199
NCT00001457
September 1995
September 2005
Name | Location |
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Bethesda, Maryland 20892 |