Combination Drug Therapy for Patients With Hepatitis C
Status:
Completed
Trial end date:
2002-09-01
Target enrollment:
Participant gender:
Summary
Hepatitis C is a major cause of liver disease in the United States and leads to cirrhosis of
the liver in approximately one-third of patients some of whom will ultimately suffer from
liver failure or liver cancer. At present, the recommended therapy of hepatitis C is the
combination of alpha interferon and ribavirin given for 6 to 12 months. Ribavirin is a
antiviral drug that is given by mouth. Interferon is both an antiviral and an immune
medication which must be given by injections (three times a week) and has many difficult side
effects. The purpose of this study is to determine whether the combination of ribavirin and
interferon improve the liver disease of hepatitis C and whether improvements can be
maintained by continuing ribavirin therapy long-term. This study will take 100 to 120
patients suffering from hepatitis C and place them under combination drug therapy with alpha
interferon and ribavirin. The course of drug therapy is scheduled to last 6 to 12 months.
Patients will be selected after appropriate screening for hepatitis C virus and elevated
liver enzymes are conducted and liver biopsy shows chronic hepatitis with some degree of
injury and scarring.
During the first 6 months of the study, subjects will be asked to return to the outpatient
clinic for routine check-ups and blood tests every 2 to 4 weeks. Blood tests will include
tests for hepatitis C virus. If the virus test becomes negative on treatment, the therapy
will be considered successful and will be continued for a full 6 or 12 months (depending upon
the strain of virus).
If the virus test does not become negative during the first six months of treatment, subjects
will be considered "non-responders" and will stop taking interferon but will continue on
ribavirin alone or an identically appearing placebo tablet. These non-responsive subjects
will continue this therapy for an additional 12 months. (A year-and-a-half total).
Upon completion of the drug therapies, subjects will be requested to submit blood samples and
undergo a liver biopsy to determine if the therapy was successful. Test results that reveal a
loss of hepatitis C antibodies or normal levels of liver enzymes will be deemed successful.
Patients that have successful laboratory test results will be considered for continuation of
ribavirin therapy. Patients that received placebo for a year will be eligible to receive
ribavirin long-term at the end of the study.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)