Long-Term Therapy With Ribavirin for Chronic Hepatitis C
Status:
Completed
Trial end date:
2008-01-15
Target enrollment:
Participant gender:
Summary
Chronic hepatitis C is a disease of the liver caused by the hepatitis C virus. The disease
can be serious and even fatal. Approximately 25% of patients with chronic hepatitis C will
develop cirrhosis and some of these patients will develop cancer of the liver or liver
failure.
Presently the disease is treated with a combination of alpha interferon or peginterferon
(antiviral and immune stimulating drugs) and ribavirin (an antiviral drug). Alpha interferon
is given by injection three times a week whereas peginterferon is given by injection only
once a week. Ribavirin is given as a tablet by mouth twice a day. The combination therapy is
given for 6 to months. About half of the patients given these medications will receive a
lasting benefit and many patients do not respond well to the combination therapy.
This study will select up to 50 patients will chronic hepatitis C who have not responded to
combination therapy or who could not stand the side effects associated with interferon or
peginterferon therapy. These subjects will be evaluated and undergo liver biopsy to determine
their present liver condition. If selected as subjects they will be started on single drug
therapy with ribavirin. The drug will be given orally twice a day at a dose based on the
patient's body weight.
The patients will be followed on an out-patient basis. They will we asked to return for
regular check-ups and blood tests every 2 to 8 weeks for the duration of the study. After 6
months, the medication will be stopped or adjusted based on the results of the subject's
blood tests (liver enzymes). A response is considered if a decrease of 50% or more of the
initial liver enzyme (alanine aminotransferase, ALT) is noted. A complete response will be
considered if liver enzymes return to normal levels.
Therapy will be discontinued after 6 months if patients do not respond. However, patients
that respond to the single drug therapy will continue to receive the medication at a
decreased dose. The patients will remain on an appropriate dose for up to 8 years with repeat
liver biopsies at 2, 4 and 8 years to assess progress.
This study will determine if long-term therapy with ribavirin is safe and effective.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)